Recognized standard
7176-28 First edition 2012-10-1
FDA recognition 16-199 · ISO · Physical Medicine
Key facts
| Recognition number | 16-199 |
|---|---|
| Designation | 7176-28 First edition 2012-10-1 |
| Title | Wheelchairs Part 28: Requirements and test methods for stairclimbing devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Physical Medicine |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 2 |
| Scope (excerpt) | ISO 7176-28:2012 is applicable to stair-climbing chairs and stair-climbing wheelchair carriers where the stair-climbing device climbs backwards up the stairs, with the occupant facing downstairs, and climbs forwards down the stairs with the occupant also facing downstairs. ISO 7176-28:2012 is… |
At a glance
- 1–9 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: