The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omniprobe Electrical Nerve Stimulator.
| Device ID | K831147 |
| 510k Number | K831147 |
| Device Name: | OMNIPROBE ELECTRICAL NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | OMNI INTL., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-08 |
| Decision Date | 1983-07-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858703006054 | K831147 | 000 |