ISB — Stimulator, Muscle, Diagnostic Class II
FDA product code ISB covers "Stimulator, Muscle, Diagnostic", a Class II medical device regulated under 21 CFR 890.1850. Submissions are reviewed by the Physical Medicine panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ISB
- Device Class
- Class II
- Regulation Number
- 890.1850
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K842805 | robert bosch | IMPULS 3, IT SELECTOR | August 1, 1984 |
| K842262 | pirdy | PIRD-Y | June 28, 1984 |
| K790949 | rami international | GALVANIC UNIT | August 16, 1979 |
| K780632 | med general | MAXICEPTOR | August 14, 1978 |
| K780730 | jay-mar international enterprises, in | FIGURETRIM | May 9, 1978 |