The following data is part of a premarket notification filed by Rehabilicare, Inc. with the FDA for Promax-xp, Tens And Microcurrent Device; Promax-tens, Tens Device; Promax-libra, Tens Device; Promax-mc, Microcurrent.
| Device ID | K011017 |
| 510k Number | K011017 |
| Device Name: | PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Contact | Edward F Valdez |
| Correspondent | Edward F Valdez REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton, MN 55112 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-09-24 |