The following data is part of a premarket notification filed by Stimwave Technologies Incorporated with the FDA for Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit.
| Device ID | K180981 |
| 510k Number | K180981 |
| Device Name: | Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach, FL 33064 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene Stimwave Technologies Incorporated 1310 Park Central Boulevard South Pompano Beach, FL 33064 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-13 |
| Decision Date | 2018-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818225020570 | K180981 | 000 |
| 00859619004943 | K180981 | 000 |
| 00859619004967 | K180981 | 000 |
| 00818225020068 | K180981 | 000 |
| 00818225020334 | K180981 | 000 |
| 00818225020501 | K180981 | 000 |
| 00818225020525 | K180981 | 000 |
| 00818225020532 | K180981 | 000 |
| 00818225020549 | K180981 | 000 |
| 00818225020556 | K180981 | 000 |
| 00818225020563 | K180981 | 000 |
| 00859619004646 | K180981 | 000 |