ISB · Stimulator, Muscle, Diagnostic
Physical Medicine · 21 CFR 890.1850 · Class 2
Overview
| Product Code | ISB |
|---|---|
| Device Name | Stimulator, Muscle, Diagnostic |
| Regulation | 21 CFR 890.1850 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K842805 | IMPULS 3, IT SELECTOR | Robert Bosch Corp. | Aug 1, 1984 | SESE |
| K842262 | PIRD-Y | Pirdy, Inc. | Jun 28, 1984 | SESE |
| K790949 | GALVANIC UNIT | Rami International Corp. | Aug 16, 1979 | SESE |
| K780632 | MAXICEPTOR | Med General | Aug 14, 1978 | SESE |
| K780730 | FIGURETRIM | Jay-Mar INternational Enterprises, IN | May 9, 1978 | SESE |
Top Applicants
- Jay-Mar INternational Enterprises, IN — 1 clearance
- Med General — 1 clearance
- Pirdy, Inc. — 1 clearance
- Rami International Corp. — 1 clearance
- Robert Bosch Corp. — 1 clearance
