The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Trans Elec Nerve Stim/muscle Stim Elec W/poly Gel.
| Device ID | K914871 |
| 510k Number | K914871 |
| Device Name: | TRANS ELEC NERVE STIM/MUSCLE STIM ELEC W/POLY GEL |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Lora L Jones |
| Correspondent | Lora L Jones LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1991-12-18 |