The following data is part of a premarket notification filed by New Dimensions In Medicine, Inc. with the FDA for Monoblock Prostoperative Tens Electrode.
| Device ID | K832145 |
| 510k Number | K832145 |
| Device Name: | MONOBLOCK PROSTOPERATIVE TENS ELECTRODE |
| Classification | Electrode, Cutaneous |
| Applicant | NEW DIMENSIONS IN MEDICINE, INC. 3040 EAST RIVER RD. P.O. BOX 1408 Dayton, OH 45401 |
| Contact | John E Shumway |
| Correspondent | John E Shumway NEW DIMENSIONS IN MEDICINE, INC. 3040 EAST RIVER RD. P.O. BOX 1408 Dayton, OH 45401 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-05 |
| Decision Date | 1983-07-19 |