Wheelchair and Scooter Testing for FDA 510(k): ISO 7176 and ANSI/RESNA WC-1/WC-2

This page is for regulatory and quality engineers preparing an FDA 510(k) for a powered wheelchair, mobility scooter or mechanical wheelchair; for importers and sourcing managers who need to check a supplier's test evidence; and for Chinese manufacturers exporting these products to the United States. It explains how FDA classifies these devices, which wheelchair standards and editions FDA currently recognizes, and exactly which of them SUNGO's Hefei laboratory is accredited to test.

All accredited wheelchair and scooter testing described here is performed by HEFEI SUNGO MEDICAL TECHNOLOGY CO., LTD., accredited by CNAS and IAS, both signatories to the ILAC MRA. Accreditation confirms the laboratory's competence for the listed methods. Whether a set of test data is adequate for a particular 510(k) is decided by FDA, not by the laboratory. If you already have a test list, send it to us and we will mark which accredited scope covers each item.

Key points

• FDA product codes: ITI (powered wheelchair, 21 CFR 890.3860, Class II), INI (motorized three-wheeled vehicle, 21 CFR 890.3800, Class II) and IOR (mechanical wheelchair, 21 CFR 890.3850, Class I). FDA's classification database lists 510(k) as the submission type for all three.
• FDA recognizes both ISO 7176 parts and the corresponding sections of ANSI/RESNA WC-1:2019 and WC-2:2019 as consensus standards.
• For each ISO 7176 part in Hefei's CNAS scope, the accredited edition is the edition FDA currently recognizes. CNAS covers most parts for listed clauses or items only (see the table); for ISO 7176-25 and -31 the CNAS clause coverage is notably partial, while IAS lists both as whole standards.
• ANSI/RESNA WC-1 and WC-2, ISO 7176-21 (EMC) and ISO 7176-30 are tested by the Hefei laboratory within IAS accreditation TL-1119 only; they are not in the CNAS or CMA scopes.
• Not offered: crash testing (ISO 7176-19, RESNA WC-4), stand-up wheelchairs (ISO 7176-20, WC-1 Section 20) and stair-climbing devices (ISO 7176-28).
• Biocompatibility is not within SUNGO's CNAS/IAS scope. Where needed, it is performed by an external subcontracted laboratory, with the client's prior consent, and identified as subcontracted in the report. SUNGO has no GLP certification.

How FDA classifies wheelchairs and scooters

The three product codes below cover the wheelchair and scooter 510(k)s we are most often asked about. The data come from FDA's product classification database (checked November 2026). Confirm the code against your predicate device before you plan testing.

Three details are easy to miss:

• IOR is Class I, but 21 CFR 890.3850 contains no exemption from premarket notification and the database lists 510(k) as its submission type. Do not assume a mechanical wheelchair is 510(k)-exempt; check the classification page for the current status.
• FDA notes on the ITI page that this device type is not intended to climb stairs; stair-climbing devices fall under product code IMK.
• Each classification page lists the recognized consensus standards that apply to the code and links FDA's product-specific guidance, Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles (July 1995).

FDA-recognized wheelchair standards and the editions Hefei tests to

FDA recognizes two parallel families of wheelchair standards. ISO 7176 is the international series. ANSI/RESNA WC-1 (Volume 1: requirements and test methods for wheelchairs, including scooters) and WC-2 (Volume 2: additional requirements for wheelchairs, including scooters, with electrical systems) are American National Standards published by RESNA. Most sections carry the same number and topic as the corresponding ISO 7176 part; for example, WC-1 Section 1 and ISO 7176-1 both cover static stability. Titles and scopes are not always identical, so check the section text: WC-1 Section 16 covers resistance to ignition of upholstered parts, and WC-2 Section 25 covers batteries and chargers for powered wheelchairs, while ISO 7176-25 covers lead-acid batteries and chargers. FDA has recognized the 2019 editions of WC-1 and WC-2 section by section.

The table maps typical 510(k) bench tests to the FDA-recognized consensus standard (recognition number and recognized edition) and to Hefei's accreditation. For example, ISO 7176-14 third edition 2022 is an FDA-recognized consensus standard (recognition number 16-234), and Hefei's CNAS scope lists ISO 7176-14:2022. CNAS entries give the edition and the clauses or items listed in the CNAS scope for L24279. The IAS scope for TL-1119 lists standards without edition years, so no year is given for IAS. CMA is shown for completeness only; it is valid within mainland China only.

Recognition data are from the FDA Recognized Consensus Standards database, checked November 2026. ANSI/RESNA WC-1 and WC-2 appear in Hefei's IAS scope as whole standards without edition year; they are not in the CNAS or CMA scopes, so a report that cites RESNA sections is issued under IAS accreditation only.

Edition points to watch

• EMC. ISO 7176-21 third edition 2025-04 is an FDA-recognized consensus standard (recognition number 16-240). FDA states that its recognition of the 2009 second edition (recognition number 16-166) will be superseded by 16-240, and that it will accept declarations of conformity to 16-166 until July 2, 2028. 16-166 is a partial recognition: FDA does not recognize clauses 5.2.2, 5.2.3, 5.2.4, 5.3.5, 5.3.6, 5.4.5 and 5.4.6 (electrostatic discharge, radiated RF field and power-frequency magnetic field immunity). ISO 7176-21 testing is performed by the Hefei laboratory, within IAS accreditation TL-1119. The IAS scope lists ISO 7176-21 without an edition year; confirm the edition with us before planning. Related: EMC testing.
• Flammability. FDA recognizes ISO 16840-10 second edition 2021-06, corrected version 2022-01 (16-233), and WC-1:2019 Section 16 (16-221). Hefei's CNAS scope lists ISO 16840-10:2021/Amd 1:2024; FDA's recognition 16-233 does not list the 2024 amendment. ISO has withdrawn ISO 7176-16:2012 and lists ISO 16840-10:2021 as its replacement. ISO also lists a third edition of ISO 16840-10 as under publication, to replace the 2021 edition. Agree the version to be cited with us before testing starts.
• RESNA revisions. The editions FDA recognizes are WC-1:2019 and WC-2:2019. RESNA's wheelchair standards page reports that a revision of WC-1:2019 Section 15 (information, documentation and labeling) went out for ANSI public review, with comments closing November 3, 2025. Check which edition FDA recognizes at the time you submit.
• Batteries. CNAS coverage of ISO 7176-25 and ISO 7176-31 is limited to the clauses listed above; IAS lists both parts as whole standards. IEC 62133 and the UN 38.3 transport tests are not in SUNGO's scope.

What SUNGO does not offer for wheelchairs

• Wheelchairs used as seats in motor vehicles and related crash or transportation testing: ISO 7176-19 (FDA recognition 16-236), RESNA WC-4:2017 Sections 10, 18, 19 and 20 (16-226 to 16-229), and ISO 10542.
• Stand-up wheelchairs: ISO 7176-20, and the corresponding WC-1:2019 Section 20 (16-222). Although Hefei's IAS scope lists ANSI/RESNA WC-1 as a whole standard, we do not offer Section 20.
• Stair-climbing devices: ISO 7176-28 (16-199).
• Biocompatibility of patient-contacting materials (for example cytotoxicity, sensitization and irritation under the ISO 10993 series), including the biocompatibility clauses EN 12183 5.6 and EN 12184 6.6. These are not within SUNGO's CNAS/IAS scope. If your submission needs them, they are performed by an external subcontracted laboratory, with the client's prior consent, and identified as subcontracted in the report. SUNGO has no GLP certification.

Planning the test program

ISO 7176 or RESNA in the report?

FDA recognizes both. ISO-based reports can be issued under CNAS for the editions and clauses listed above, or under IAS; reports citing RESNA WC-1 or WC-2 are within IAS accreditation only. The standards cited in your predicate device's 510(k) summary are a practical starting point, but the final choice is yours and the acceptance decision is FDA's.

Configuration and set-up

ISO 7176-22 (set-up procedures) and ISO 7176-11 (test dummies) govern how the device is configured and loaded for testing; both are in Hefei's CNAS, CMA and IAS scopes (CNAS and CMA for the clauses or items shown in the table). Tell us the configuration you intend to declare, including seat, backrest, battery, charger and controller options, so the results describe the device in your submission.

Medicare coding

Medicare coding is a separate matter from FDA clearance. RESNA's wheelchair standards page notes that the Centers for Medicare & Medicaid Services (CMS) and Medicare Pricing, Data Analysis and Coding (PDAC) establish coding guidelines and policy for mobility technologies. SUNGO does not claim PDAC acceptance of its reports; confirm any PDAC requirements with PDAC directly.

EU route in brief

Under the EU Medical Device Regulation, wheelchairs are generally Class I under Annex VIII: Rule 13 (all other active devices) for powered wheelchairs and Rule 1 (non-invasive devices) for manual wheelchairs. MDCG 2021-24 Rev.1 (April 2026) lists electric wheelchairs as a Rule 13 Class I example and wheelchairs pushed by hand as a Rule 1 example. Classification and conformity assessment remain the manufacturer's responsibility, together with a notified body where the MDR requires one. Hefei's European wheelchair scope:

• EN 12183:2022 (manual wheelchairs). CNAS lists clauses 5.2, 5.4, 5.5, 5.7 to 5.14, 6, 7.1 to 7.3, 7.5, 8.1 to 8.5, 9.1 to 9.3, 10.1 to 10.6, 11 and 12. IAS covers the standard except 5.6 Biocompatibility and toxicity.
• EN 12184:2022 (electrically powered wheelchairs, scooters and their chargers). CNAS lists clauses 6.2, 6.4, 6.5, 6.7 to 6.14, 6.16, 6.17, 7, 8.1.2 to 8.1.9, 8.2, 8.3, 9.1 to 9.5, 10.1 to 10.3, 11.1 to 11.6, 12.1 to 12.8 and 13. IAS covers the standard except 6.6 Biocompatibility and toxicity and 12.3.1.

Accreditation at a glance

Shanghai SUNGO Medical Technology Co., Ltd. and HEFEI SUNGO MEDICAL TECHNOLOGY CO., LTD. are two independent legal entities; Hefei is not a branch of Shanghai. All accredited wheelchair testing is done at the Hefei laboratory; biocompatibility, where needed, is subcontracted as described above. Hefei laboratory address: Unit 03, Building 7, Wanmao Industrial Park, Pengyi Road, Zipeng Town, Feixi County, Hefei, Anhui.

What to send us / how to start

1. The product code you intend to use (ITI, INI or IOR), the intended use statement and the model list, including variants and options.
2. Your predicate device and, if available, the standards list from its 510(k) summary, plus the standards and editions you want cited (ISO 7176, RESNA WC-1/WC-2, or both).
3. Key specifications needed to set up tests: rated occupant mass, maximum speed, dimensions, battery chemistry (lead-acid or lithium-ion), charger and controller models.
4. Draft user manual and labels, used for ISO 7176-15 and for the instructions-for-use and battery-label clauses of ISO 7176-31 (clauses 6 and 7).
5. Battery and charger documentation, including any existing test reports.
6. Production-equivalent samples in the configuration you intend to declare. Sample quantity depends on the test plan and is set per the standard; we confirm it when we quote.
7. The accreditation mark you need on each report (CNAS or IAS), since some items are available under only one of them, and, if biocompatibility is needed, a list of patient-contacting materials and your consent to subcontracting.

Shipping-package testing for the boxed product is a separate service; see transport testing. For an overview of all service lines, see our services and the wheelchair testing service page. When you are ready, contact us with your documents.

FAQ

Will FDA accept your test reports?

FDA decides whether test data are adequate for a given 510(k); no laboratory can guarantee acceptance. The Hefei laboratory is accredited by CNAS and IAS, both signatories to the ILAC MRA, and you can check each test item against the published scopes linked on this page.

Should we test to ISO 7176 or to RESNA WC-1/WC-2?

FDA recognizes both families. For each ISO 7176 part in Hefei's CNAS scope, the accredited edition matches the FDA-recognized edition, mostly for listed clauses or items only. ISO 7176-21 and -30 and the RESNA WC-1/WC-2 standards are within IAS accreditation only.

Can you perform ISO 7176-21 EMC testing on our powered wheelchair?

Yes. ISO 7176-21 is performed by the Hefei laboratory, within IAS accreditation TL-1119; it is not in the CNAS or CMA scopes, and the IAS scope lists it without an edition year, so confirm the edition with us before planning. FDA recognizes the 2025 edition (16-240) and will accept declarations of conformity to the 2009 edition (16-166, a partial recognition that excludes the ESD, radiated RF and power-frequency magnetic field immunity clauses) until July 2, 2028.

Do you test lithium-ion battery systems?

Yes, to ISO 7176-31 at Hefei: CNAS covers ISO 7176-31:2023 clauses 4.2.2, 4.2.4, 5.2.1.3, 5.2.1.5 to 5.2.1.7, 6 and 7, and IAS lists the whole standard. IEC 62133 and UN 38.3 transport tests are not in SUNGO's scope.

Do you offer crash, stand-up or stair-climbing wheelchair testing?

No. ISO 7176-19 and RESNA WC-4, ISO 7176-20 and WC-1 Section 20 (stand-up wheelchairs), and ISO 7176-28 (stair-climbing devices) are not offered.

How is biocompatibility handled?

Biocompatibility is not within SUNGO's CNAS/IAS scope. If needed, it is performed by an external subcontracted laboratory, with the client's prior consent, and identified as subcontracted in the report. SUNGO has no GLP certification.

Next step

Send us your product code, predicate and target standards, and we will reply with a test plan that shows, item by item, which accredited scope applies and what falls outside it. Contact SUNGO Lab.