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 |