Recognized standard
11199-1 Second edition 2021-05
FDA recognition 16-238 · ISO · Physical Medicine
Key facts
| Recognition number | 16-238 |
|---|---|
| Designation | 11199-1 Second edition 2021-05 |
| Title | Assistive products for walking manipulated by both arms - Requirements and test methods Part 1: Walking frames |
| 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 for walking frames used as assistive products for walking, manipulated by both arms, without accessories, unless specified in the particular test procedure. This document also gives requirements relating to safety, ergonomics, performance and… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
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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: