The following data is part of a premarket notification filed by Oms Medical Supplies, Inc. with the FDA for Mstim-2000 Ems.
| Device ID | K904332 |
| 510k Number | K904332 |
| Device Name: | MSTIM-2000 EMS |
| Classification | Stimulator, Muscle, Powered |
| Applicant | OMS MEDICAL SUPPLIES, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Thomas Riihimaki |
| Correspondent | Thomas Riihimaki OMS MEDICAL SUPPLIES, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-21 |
| Decision Date | 1991-05-01 |