The following data is part of a premarket notification filed by Stimwave Technologies Incorporated with the FDA for Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit And Charger Kit.
| Device ID | K162161 |
| 510k Number | K162161 |
| Device Name: | Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit And Charger Kit |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | Stimwave Technologies Incorporated 901 East Las Olas Boulevard, Suite 201 Fort Lauderdale, FL 33301 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene Stimwave Technologies Incorporated 901 East Las Olas Boulevard, Suite 201 Fort Lauderdale, FL 33301 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-02 |
| Decision Date | 2016-12-16 |
| Summary: | summary |