The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rich-mar Cm-ii Combined Muscle Stimulator, Interferential, Tens & Therapeutic Ultrasound Device.
Device ID | K952089 |
510k Number | K952089 |
Device Name: | RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE |
Classification | Interferential Current Therapy |
Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 -0879 |
Contact | David Richards |
Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 -0879 |
Product Code | LIH |
Subsequent Product Code | GZJ |
Subsequent Product Code | IMG |
Subsequent Product Code | IMI |
Subsequent Product Code | IPF |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-03 |
Decision Date | 1995-08-11 |