IPT
5 FDA 510(k) clearances · Product code
25 daysmedian time to decision
154 days90th percentile
5clearances measured
FDA profile
- Official device name
- Orthosis, Thoracic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3490
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 1992: 1 · 2000: 1
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 |
|---|---|---|
| VOLLMAN PRONE POSITIONER (K963091) | Hill-Rom, Inc. | 1997-01-09 |
| BACK SKPPORTS (K821645) | Fred Sammons, Inc. | 1982-06-11 |
| CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O (K812401) | Surgical Appliance Industries, Inc. | 1981-09-14 |
| MULTITUBULAR THORACIC AIR SPLINTS (K811750) | Roger Cestac & Assoc. | 1981-07-20 |
| LATERAL TRUNK SUPPORTS (K761128) | Fred Sammons, Inc. | 1976-12-02 |
Track IPT automatically
Every clearance here is in the API, with alerts when new ones post.