The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Home Microcurrent Hmc.
Device ID | K935132 |
510k Number | K935132 |
Device Name: | HOME MICROCURRENT HMC |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, MN 55112 |
Contact | Daniel D Pilon |
Correspondent | Daniel D Pilon MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul, 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 | 1993-10-28 |
Decision Date | 1994-03-14 |