Recognized standard
11199-2 Third edition 2021-07 [Including AMD1:2024]
FDA recognition 16-239 · ISO · Physical Medicine
Key facts
| Recognition number | 16-239 |
|---|---|
| Designation | 11199-2 Third edition 2021-07 [Including AMD1:2024] |
| Title | Assistive products for walking manipulated by both arms - Requirements and test methods Part 2: Rollators [Including Amendment 1 (2024)]. |
| Standards developer | International Organization for Standardization |
| Specialty area | Physical Medicine |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | This document specifies requirements and test methods of rollators being used as assistive products for walking with wheels, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: