The following data is part of a premarket notification filed by Myomed, Inc. with the FDA for Accu-o-matic.
| Device ID | K841427 |
| 510k Number | K841427 |
| Device Name: | ACCU-O-MATIC |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | MYOMED, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-06 |
| Decision Date | 1985-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628235150057 | K841427 | 000 |