The following data is part of a premarket notification filed by Stimwave Technologies Inc.,dba Stimq Llc with the FDA for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Swag Kit, Swag Accessory Kit, Charger Kit.
| Device ID | K171366 |
| 510k Number | K171366 |
| Device Name: | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit |
| Classification | Stimulator, Peripheral Nerve, Implanted (pain Relief) |
| Applicant | Stimwave Technologies Inc.,DBA StimQ LLC 901 East Las Olas Boulevard , Suite 201 Fort Lauderdale, FL 33301 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene Stimwave Technologies Inc., DBA StimQ LLC 901 East Las Olas Boulevard , Suite 201 Fort Lauderdale, FL 33301 |
| Product Code | GZF |
| CFR Regulation Number | 882.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818225020815 | K171366 | 000 |
| 00818225020495 | K171366 | 000 |
| 00818225020709 | K171366 | 000 |
| 00818225020716 | K171366 | 000 |
| 00818225020723 | K171366 | 000 |
| 00818225020730 | K171366 | 000 |
| 00818225020747 | K171366 | 000 |
| 00818225020754 | K171366 | 000 |
| 00818225020761 | K171366 | 000 |
| 00818225020778 | K171366 | 000 |
| 00818225020785 | K171366 | 000 |
| 00818225020792 | K171366 | 000 |
| 00818225020808 | K171366 | 000 |
| 00818225020464 | K171366 | 000 |