ISB
5 FDA 510(k) clearances · Product code
21 daysmedian time to decision
119 days90th percentile
5clearances measured
FDA profile
- Official device name
- Stimulator, Muscle, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1850
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMPULS 3, IT SELECTOR (K842805) | Robert Bosch Corp. | 1984-08-01 |
| PIRD-Y (K842262) | Pirdy, Inc. | 1984-06-28 |
| GALVANIC UNIT (K790949) | Rami International Corp. | 1979-08-16 |
| MAXICEPTOR (K780632) | Med General | 1978-08-14 |
| FIGURETRIM (K780730) | Jay-Mar INternational Enterprises, IN | 1978-05-09 |
Track ISB automatically
Every clearance here is in the API, with alerts when new ones post.