The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Tens Electrode Snap Type, Disposa., Self-adhering.
| Device ID | K880649 |
| 510k Number | K880649 |
| Device Name: | TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING |
| Classification | Electrode, Cutaneous |
| Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
| Contact | Michael S Bartlett |
| Correspondent | Michael S Bartlett 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 | 1988-02-17 |
| Decision Date | 1988-03-04 |