The following data is part of a premarket notification filed by Hb Medical, Inc. with the FDA for Hbotc Muscle And Nerve Stimulator.
| Device ID | K160255 |
| 510k Number | K160255 |
| Device Name: | HBOTC Muscle And Nerve Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | HB MEDICAL, INC. 5702 BOLSA AVENUE Huntington Beach, CA 92649 |
| Contact | Ryan Heaney |
| Correspondent | Robyn Scopis REGULATORY SPECIALISTS, INC. 3722 AVE. SAUSALITO Irvine, CA 92831 |
| Product Code | NUH |
| Subsequent Product Code | IPF |
| Subsequent Product Code | NGX |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869844000221 | K160255 | 000 |