The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Model 2060 W/6 Cm(2) & Model 2100 W/10 Cm(2) Trans.
| Device ID | K864653 |
| 510k Number | K864653 |
| Device Name: | MODEL 2060 W/6 CM(2) & MODEL 2100 W/10 CM(2) TRANS |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
| Contact | David Richards |
| Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-28 |
| Decision Date | 1986-12-29 |