The following data is part of a premarket notification filed by Stimwave Technologies Incorporated with the FDA for Freedom Spinal Cord Stimulator System.
| Device ID | K160600 |
| 510k Number | K160600 |
| Device Name: | Freedom Spinal Cord Stimulator System |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | STIMWAVE TECHNOLOGIES INCORPORATED 901 E LAS OLAS BLVD, SUITE 201 Fort Lauderdale, FL 33301 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene STIMWAVE TECHNOLOGIES INCORPORATED 901 E LAS OLAS BLVD, 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 | 2016-03-02 |
| Decision Date | 2016-08-26 |
| Summary: | summary |