IPR
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Crutch
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3150
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2011: 15 · 2012: 34 · 2013: 64 · 2014: 53 · 2015: 12 · 2016: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIGHT WEIGHT ALUMINUM CRUTCHES (K821403) | Manuco Manufacturing Co., Inc. | 1982-06-21 |
| FOLDING CRUTCH (K800237) | Husa Folding Crutch Co., Inc. | 1980-02-22 |
| CRUTCH (K790557) | Maddak, Inc. | 1979-04-03 |
| SWIVEL HEAD ADJUSTABLE CRUTCH (K770146) | Maddak, Inc. | 1977-01-28 |
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Every clearance here is in the API, with alerts when new ones post.