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 |