The following data is part of a premarket notification filed by Technalithics Laboratories, Inc. with the FDA for Model Hs-2 Tens Device.
| Device ID | K962951 |
| 510k Number | K962951 |
| Device Name: | MODEL HS-2 TENS DEVICE |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | TECHNALITHICS LABORATORIES, INC. 7003 WOODWAY DR., SUITE 315 Waco, TX 76712 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-26 |
| Decision Date | 1997-08-06 |