The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Spect.e.n.s Repositionable, Snap-type, Tens.
| Device ID | K894043 |
| 510k Number | K894043 |
| Device Name: | SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS |
| Classification | Electrode, Cutaneous |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Lora Jones |
| Correspondent | Lora Jones LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-06 |
| Decision Date | 1989-08-11 |