Wheelchairs for the US: ANSI/RESNA WC-1 and WC-2 Testing Guide

If you make manual wheelchairs, powered wheelchairs or scooters for the US market, the same questions come up early in every project: what do ANSI/RESNA WC-1 and WC-2 each cover, how do they relate to the ISO 7176 series, and which edition and which sections appear in the FDA Recognized Consensus Standards database? This guide answers those questions from RESNA's own website and the FDA database, then explains how the SUNGO Hefei laboratory handles WC-1 and WC-2 testing within its IAS accreditation (TL-1119) and what to prepare before you send samples.

Key points

• WC-1 is Volume 1 of the American National Standard for Wheelchairs (requirements and test methods). It applies to manual wheelchairs, powered wheelchairs and scooters. WC-2 is Volume 2, which sets additional requirements for wheelchairs (including scooters) with electrical systems. Powered products usually need both volumes.
• RESNA states that the sections of WC-1 and WC-2 were harmonized, where possible, with the parallel parts of the ISO 7176 series. Judging by the section titles RESNA lists, every section except Section 0 shares its number with an ISO 7176 part. They are still separately published standards, so the standard texts themselves decide any differences.
• The FDA Recognized Consensus Standards database lists 12 sections of WC-1:2019 and 8 sections of WC-2:2019 as separate entries, with recognition numbers 16-207 to 16-225 and 16-230. Every entry shows "Complete standard" as the extent of recognition (checked October 2026).
• At SUNGO, WC-1 and WC-2 are tested by the Hefei laboratory (Hefei SUNGO Medical Technology Co., Ltd.). Both are listed as whole standards in its IAS scope of accreditation (TL-1119), with no exclusions and no edition year.
• If your product also needs biological tests such as cytotoxicity, sensitization or irritation, SUNGO subcontracts them to an appropriately qualified laboratory. Under accreditation rules, the client's agreement is obtained before subcontracting, and the report identifies the subcontracted tests and the subcontractor.

The standards and what they cover

WC-1: requirements and test methods for wheelchairs (including scooters)

According to RESNA, WC-1 applies to manual and powered wheelchairs, including scooters, and to accessories for wheelchairs and scooters. It specifies vocabulary, disclosure requirements for testing, and test methods and methods of measurement for static stability, wheelchair and seat dimensions, static, impact and fatigue strength, flammability, test dummy specifications and set-up procedures. RESNA lists Sections 0, 1, 3, 5, 7, 8, 11, 13, 15, 16, 20, 22 and 26 in WC-1. The section titles are in the table below.

WC-2: additional requirements for wheelchairs (including scooters) with electrical systems

RESNA describes WC-2 as applying to powered wheelchairs, including scooters, and their accessories. It specifies test methods and requirements for dynamic stability, brake effectiveness, energy consumption, maximum speed, acceleration and deceleration, obstacle climbing, climatic testing, the power and control system, and electromagnetic compatibility. WC-2 contains Sections 2, 4, 6, 9, 10, 14, 21 and 25.

The FDA database summaries for two WC-2 sections are more specific about scope:

• Section 21 (EMC) covers electrically powered wheelchairs and motorized scooters for indoor and outdoor use by people with disabilities, and also manual wheelchairs with an add-on power kit. It does not apply to vehicles designed to carry more than one person. The section also covers EMC requirements and test methods for battery chargers used with powered wheelchairs and scooters.
• Section 25 (batteries and chargers) applies to lead-acid batteries and the chargers intended for use with them.

For lithium-ion products, the matching international standard is ISO 7176-31 (lithium-ion battery systems and chargers for powered wheelchairs). The FDA database recognizes the 2023-05 edition of ISO 7176-31 under recognition number 16-241. Separately, the Hefei laboratory's IAS scope (TL-1119) also lists ISO 7176-31, with no edition year.

How WC-1 and WC-2 relate to ISO 7176

In a June 7, 2019 announcement, RESNA said both volumes had undergone extensive review and revision since the 2009 edition, and that its committee had harmonized the sections with the parallel parts of the ISO 7176 series where possible. Judging by the section titles on the RESNA site, every section except Section 0 (test reports) shares its number with an ISO 7176 part: Section 1 and ISO 7176-1 both cover static stability, and Section 21 and ISO 7176-21 both cover EMC of powered wheelchairs.

Two cautions apply. First, harmonized does not mean identical. RESNA says "where possible" and does not claim that each section matches the ISO text, so the standard texts decide any differences. For example, RESNA Section 16 is titled resistance to ignition of upholstered parts, while ISO 7176-16 in the Hefei IAS scope is titled resistance to ignition of postural support devices: same number, different title. Second, RESNA sections and ISO parts are revised on different timelines, so always compare specific editions.

The table below puts each WC section, its FDA recognition number (2019 edition) and the same-numbered ISO 7176 part side by side. The last column only shows whether that ISO part is also in the Hefei IAS scope, which tells you whether a separate ISO-based report can be issued within the IAS scope. WC-1 and WC-2 themselves are listed in the Hefei IAS scope as whole standards, and the applicable sections are confirmed product by product when we accept the request.

The Hefei IAS scope also includes ISO 7176-30 (wheelchairs for changing occupant posture) and ISO 7176-31 (lithium-ion battery systems and chargers). Neither has a same-numbered section in WC-1 or WC-2.

Use in motor vehicles is covered separately by RESNA WC-4 (Volume 4: Wheelchairs and Transportation), maintained by the Committee on Wheelchairs and Transportation (COWHAT). Its Section 19 covers wheelchairs used as seats in motor vehicles, and the related ISO work is ISO 7176-19. Neither WC-4 nor ISO 7176-19 is in the Hefei IAS scope.

Editions: 2009, 2019 and the Section 15 revision

RESNA announced in June 2019 that ANSI had approved the updated Volumes 1 and 2, replacing the 2009 publication. The FDA database currently lists the 2019 sections. When we checked in October 2026, we found no complete edition of WC-1 or WC-2 published after 2019. The public review listed on the RESNA site still concerns WC-1:2019: a revision of Section 15 went out for ANSI public review (comments closed November 3, 2025). It brings in the labeling and air travel configuration card requirements from RESNA AT-1:2021 Section 4. Check RESNA's current information to see whether the revision has been published.

So settle two things before testing: which edition to test to, and who will use the report. The Hefei laboratory's IAS scope (TL-1119) lists WC-1 and WC-2 by standard number without an edition year. The edition to be applied is confirmed with the client in writing when we accept the request, subject to the scope of accreditation.

FDA recognition status

In the FDA Recognized Consensus Standards database, WC-1 and WC-2 are listed section by section under the Physical Medicine specialty task group. As of October 2026, the 12 WC-1:2019 sections and the seven WC-2:2019 sections other than Section 25 were entered on 2019-12-23 (recognition list 053), and WC-2:2019 Section 25 on 2020-12-21 (recognition list 055). All 20 entries show "Complete standard" as the extent of recognition. We found no separate entry for WC-1 Section 0 (test reports).

The product codes on each entry are examples only, and the FDA pages note that others may apply. The WC-1 Section 8 entry (16-214), for instance, lists IOR (Wheelchair, Mechanical, §890.3850), ITI (Wheelchair, Powered, §890.3860) and INI (Vehicle, Motorized 3-Wheeled, §890.3800), among others. WC-2 entries do not list IOR, and WC-1 Section 20 lists only IPL (Wheelchair, Standup). The entries for WC-2 Sections 21 and 25 also list FDA's July 1995 guidance on preparing 510(k) applications for mechanical and powered wheelchairs and motorized three-wheeled vehicles.

The same database also lists many ISO 7176 parts as separate entries, for example the 2022 edition of ISO 7176-14 (recognition number 16-234) and the 2023-05 edition of ISO 7176-31 (16-241). Whether you cite the RESNA sections, the ISO parts or both is your call as part of your submission strategy. Recognition status changes as new lists are published, so check the current database entries before you submit.

Test scope (Hefei laboratory, IAS accreditation)

The table reproduces the two rows of the Hefei SUNGO Medical Technology Co., Ltd. IAS scope (TL-1119) that apply here. Both sit under the Electrical/Mechanical/Physical Testing category.

"Whole standard" means the scope lists the standard by number without listing individual sections or clauses. The electrical items in WC-2, including EMC (Section 21), power and control systems (Section 14) and batteries and chargers (Section 25), are also performed by the Hefei laboratory within its IAS accreditation (TL-1119). Which sections apply and how the tests are arranged are confirmed product by product when we accept the request.

Where SUNGO performs the tests and under which accreditation

• Site and legal entity: Hefei SUNGO Medical Technology Co., Ltd., an independent company (not a branch), with its laboratory in Zipeng Town, Feixi County, Hefei, Anhui Province. Shanghai SUNGO Medical Technology Co., Ltd. (laboratory at 958 Kangqiao East Road, Pudong, Shanghai) is a separate legal entity, and its accreditation scopes do not include wheelchair standards.
• Accreditation and certificate number: IAS, certificate TL-1119, effective June 4, 2026. The certificate states that the laboratory has met IAS Accreditation Criteria for Testing Laboratories (AC89) and has demonstrated compliance with ISO/IEC 17025:2017. The IAS certificate carries the ILAC-MRA mark.
• Reports: WC-1 and WC-2 test reports are issued within the IAS scope of accreditation. How a report is used with a particular overseas regulator is for the client to confirm against that regulator's requirements.
• Biocompatibility: where biological tests such as cytotoxicity, sensitization, irritation or implantation are needed, SUNGO subcontracts them to an appropriately qualified laboratory. Under accreditation rules, the client's agreement is obtained before subcontracting, and the report identifies the subcontracted tests and the subcontractor.

Preparing for testing

1. Product category: say whether the product is a manual wheelchair, a powered wheelchair, a scooter or a manual wheelchair with an add-on power kit, and add the intended FDA product code (for example IOR, ITI or INI) if you already know it. This decides whether WC-2 applies and which sections are needed.
2. Edition and intended use of the report: state which edition of WC-1 and WC-2 to use, whether you also need ISO 7176 reports, and whether the report will support a US premarket submission.
3. Models and configuration: provide the model list and the differences between models, the adjustment ranges and factory settings of adjustable parts, and the list of options. The FDA summary of WC-1 Section 8 notes that the section specifies a reference configuration for adjustable wheelchairs and scooters, so adjustment ranges need to be clear.
4. User manual, labels and specification sheet: Section 15 covers the information, documentation and labeling that the manufacturer supplies with the wheelchair or in presale specification sheets. Send the manual, label artwork and specification sheet with the samples.
5. Electrical information (powered products): battery type (lead-acid or lithium-ion) and model, charger model, controller model and software version, motor details, and the speed and range values the manufacturer declares.
6. Declared conditions of use: maximum user weight, intended environment (indoor, outdoor) and similar declarations, so that tests can be planned and declared values checked.
7. Sample condition: complete samples that match production, with all accessories, that can be assembled and set up according to the manual (Section 22 covers set-up procedures). The number of samples depends on the sections and test sequence chosen and is agreed before the order.

FAQ

Are ANSI/RESNA WC-1 and ISO 7176 the same standard?

No, but they are closely related. RESNA says the WC-1 and WC-2 sections were harmonized with the parallel ISO 7176 parts where possible, and judging by the section titles RESNA lists, every section except Section 0 shares its number with an ISO 7176 part. They are published separately and revised on different timelines, so the standard texts decide any differences.

Does a manual wheelchair need WC-2 testing?

Under RESNA's scope statement, WC-2 is for wheelchairs with electrical systems, meaning powered wheelchairs (including scooters) and their accessories, so a manual wheelchair without power mainly falls under WC-1. A manual wheelchair with an add-on power kit is different: the FDA summary of WC-2 Section 21 says that section applies to it.

Which edition of WC-1 and WC-2 does FDA recognize?

As of October 2026, the FDA Recognized Consensus Standards database lists 12 sections of WC-1:2019 and 8 sections of WC-2:2019, recognition numbers 16-207 to 16-225 and 16-230, all as "Complete standard". RESNA has put a revision of WC-1:2019 Section 15 out for public review. If the revision is published, check the current database entries to see whether FDA has recognized it.

Which SUNGO laboratory tests to WC-1 and WC-2, and under which accreditation?

The Hefei laboratory of Hefei SUNGO Medical Technology Co., Ltd. Both WC-1 and WC-2 are listed as whole standards in its IAS scope of accreditation, certificate TL-1119. The Shanghai company's scopes do not include wheelchair standards.

What if the wheelchair also needs biocompatibility testing?

Biological tests such as cytotoxicity, sensitization and irritation are subcontracted by SUNGO to an appropriately qualified laboratory. Under accreditation rules, the client's agreement is obtained in advance, and the report identifies the subcontracted tests and the subcontractor.

Requesting a quote

If you are planning ANSI/RESNA WC-1 or WC-2 testing, start with our wheelchair testing service. For EMC of powered wheelchairs and chargers, see also our EMC testing service. Send us the product category, model list, intended edition and intended use of the report through our contact page, and we will confirm the applicable sections for your product.