The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Modification To: Winner St-2 Stimulator.
| Device ID | K013770 |
| 510k Number | K013770 |
| Device Name: | MODIFICATION TO: WINNER ST-2 STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | RICH-MAR CORP. 15499 EAST 590TH RD. P.O. BOX 879 Inola, OK 74036 -0879 |
| Contact | David Richards |
| Correspondent | David Richards RICH-MAR CORP. 15499 EAST 590TH RD. P.O. BOX 879 Inola, OK 74036 -0879 |
| Product Code | IPF |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-01-18 |