Recognized standard
7176-15 First edition 1996-11-15
FDA recognition 16-27 · ISO · Physical Medicine
Key facts
| Recognition number | 16-27 |
|---|---|
| Designation | 7176-15 First edition 1996-11-15 |
| Title | Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
| Standards developer | International Organization for Standardization |
| Specialty area | Physical Medicine |
| Date of entry | Jan 30, 2014 |
| Device classes | Class 2, Class 1 |
| Scope (excerpt) | This standard specifies the information, documentation and labelling to be provided with a wheelchair at the supply by the manufacturer. |
At a glance
- 1–9 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: