The following data is part of a premarket notification filed by Futuremed Div. Of Future Impex Corp. with the FDA for Mega-tens Dual Channel T.e.n.s..
| Device ID | K903017 |
| 510k Number | K903017 |
| Device Name: | MEGA-TENS DUAL CHANNEL T.E.N.S. |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Contact | Mike Davidson |
| Correspondent | Mike Davidson FUTUREMED DIV. OF FUTURE IMPEX CORP. 2076 DEER PARK AVE. Deer Park, NY 11729 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-10 |
| Decision Date | 1990-10-26 |