The following data is part of a premarket notification filed by Alternative Design Systems, Inc. with the FDA for Tens Conductive Media Pad.
| Device ID | K853633 |
| 510k Number | K853633 |
| Device Name: | TENS CONDUCTIVE MEDIA PAD |
| Classification | Electrode, Cutaneous |
| Applicant | ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Contact | John L Essmyer |
| Correspondent | John L Essmyer ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-30 |
| Decision Date | 1985-12-03 |