The following data is part of a premarket notification filed by Stimwave Technologies Incorporated with the FDA for Freedom Spinal Cord Stimulator (scs) System.
| Device ID | K141399 |
| 510k Number | K141399 |
| Device Name: | FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | STIMWAVE TECHNOLOGIES INCORPORATED 420 Lincoln Rd Suite 365 Miami Beach, FL 33139 |
| Contact | Elizabeth Greene |
| Correspondent | Elizabeth Greene STIMWAVE TECHNOLOGIES INCORPORATED 420 Lincoln Rd Suite 365 Miami Beach, FL 33139 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-28 |
| Decision Date | 2014-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859619004028 | K141399 | 000 |
| 40859619004026 | K141399 | 000 |