Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

066

Date of Entry 05/25/2026 

FR Recognition Number

16-241

Standard

ISO  7176-31 First edition 2023-05
Wheelchairs -- Part 31: Lithium-ion battery systems and chargers for powered wheelchairs--Requirements and test methods

Scope/Abstract

This document specifies requirements and test methods for lithium-ion batteries and battery systems intended for use in electrically powered wheelchairs, and their charging systems.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§890.3800	Vehicle, Motorized 3-Wheeled	Class 2	INI
§890.3860	Wheelchair, Powered	Class 2	ITI
§890.3890	Wheelchair, Stair Climbing	Class 2	IMK
§890.3900	Wheelchair, Standup	Class 2	IPL

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contact

 Ambarish Pawar

  CDRH/OPEQ/OHTV/DHTVB

  --

  ambarish.pawar@fda.hhs.gov

Standards Development Organization

ISO International Organization for Standardization https://www.iso.org/

FDA Specialty Task Group (STG)

Physical Medicine

*These are provided as examples and others may be applicable.