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 | K182720 |
| 510k Number | K182720 |
| Device Name: | Freedom Spinal Cord Stimulator (SCS) System |
| 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 Inc. 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 | 2018-09-28 |
| Decision Date | 2019-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818225022086 | K182720 | 000 |
| 00850051034123 | K182720 | 000 |
| 00850051034116 | K182720 | 000 |
| 00850051034109 | K182720 | 000 |
| 00850051034093 | K182720 | 000 |
| 00850051034086 | K182720 | 000 |
| 00850051034079 | K182720 | 000 |
| 00850051034062 | K182720 | 000 |
| 00850051034055 | K182720 | 000 |
| 00850051034048 | K182720 | 000 |
| 00850051034031 | K182720 | 000 |
| 00850051034024 | K182720 | 000 |
| 00850051034215 | K182720 | 000 |
| 00850051034499 | K182720 | 000 |
| 00818225022079 | K182720 | 000 |
| 00818225022062 | K182720 | 000 |
| 00818225022055 | K182720 | 000 |
| 00818225022048 | K182720 | 000 |
| 00818225022031 | K182720 | 000 |
| 00818225021850 | K182720 | 000 |
| 00850051034550 | K182720 | 000 |
| 00850051034543 | K182720 | 000 |
| 00850051034529 | K182720 | 000 |
| 00850051034512 | K182720 | 000 |
| 00850051034505 | K182720 | 000 |
| 00850051034017 | K182720 | 000 |