The following data is part of a premarket notification filed by Pioneering Technologies, Inc. with the FDA for Reusable Tens Paravertebral Pad #641 Back Electrod.
| Device ID | K901575 |
| 510k Number | K901575 |
| Device Name: | REUSABLE TENS PARAVERTEBRAL PAD #641 BACK ELECTROD |
| Classification | Electrode, Cutaneous |
| Applicant | PIONEERING TECHNOLOGIES, INC. 580 ROCQUE AVE. Wabasha, MN 55981 |
| Contact | Wolfe, Cpa |
| Correspondent | Wolfe, Cpa PIONEERING TECHNOLOGIES, INC. 580 ROCQUE AVE. Wabasha, MN 55981 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-03 |
| Decision Date | 1990-05-02 |