INE
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Sling, Overhead Suspension, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3910
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1995: 2 · 2007: 2 · 2011: 11 · 2012: 12 · 2013: 40 · 2015: 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 |
|---|---|---|
| ACCULITE-PPL 5 (K884787) | Medical Alignment Systems | 1989-01-24 |
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Every clearance here is in the API, with alerts when new ones post.