The following data is part of a premarket notification filed by Savia Limited with the FDA for Tens Back Pain Relief System.
| Device ID | K113321 |
| 510k Number | K113321 |
| Device Name: | TENS BACK PAIN RELIEF SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | SAVIA LIMITED 11820 RED HIBISCUS Bonita Springs, FL 34135 |
| Contact | Guenter Ginsberg |
| Correspondent | Guenter Ginsberg SAVIA LIMITED 11820 RED HIBISCUS Bonita Springs, FL 34135 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-10 |
| Decision Date | 2012-09-04 |
| Summary: | summary |