FDA product code ISB: Stimulator, Muscle, Diagnostic
ISB is the FDA product code for stimulator, muscle, diagnostic. It is a Class II device, regulated under 21 CFR 890.1850 and reviewed by the Physical Medicine panel. FDA has cleared 5 510(k) submissions under ISB, from 5 different applicants. The average 510(k) review took 50 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Muscle, Diagnostic |
| Device class | Class II |
| Regulation | 21 CFR 890.1850 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every ISB clearance
Top ISB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Robert Bosch Corp. | 1 | 1984-08-01 |
| Pirdy, Inc. | 1 | 1984-06-28 |
| Rami International Corp. | 1 | 1979-08-16 |
| Med General | 1 | 1978-08-14 |
| Jay-Mar INternational Enterprises, IN | 1 | 1978-05-09 |
Most recent ISB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842805 | Robert Bosch Corp. | IMPULS 3, IT SELECTOR | 1984-08-01 | 15 |
| K842262 | Pirdy, Inc. | PIRD-Y | 1984-06-28 | 21 |
| K790949 | Rami International Corp. | GALVANIC UNIT | 1979-08-16 | 87 |
| K780632 | Med General | MAXICEPTOR | 1978-08-14 | 119 |
| K780730 | Jay-Mar INternational Enterprises, IN | FIGURETRIM | 1978-05-09 | 7 |
Recalls for ISB devices
openFDA lists no recalls for product code ISB.
Frequently asked questions
What is FDA product code ISB?
ISB is the FDA product code for stimulator, muscle, diagnostic. It is a Class II device, regulated under 21 CFR 890.1850 and reviewed by the Physical Medicine panel.
What device class is ISB?
Class II, regulation 21 CFR 890.1850. Typical premarket route: 510(k).
How long does a 510(k) take for product code ISB?
Across 5 cleared submissions the average was 50 days from receipt to decision (median 21).
Which companies have the most ISB clearances?
Robert Bosch Corp. (1); Pirdy, Inc. (1); Rami International Corp. (1); Med General (1); Jay-Mar INternational Enterprises, IN (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ISB
- Run a recall and safety report across every ISB manufacturer
- Watch product code ISB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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