The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs-4i Muscle Stimulator.
| Device ID | K112348 |
| 510k Number | K112348 |
| Device Name: | RS-4I MUSCLE STIMULATOR |
| Classification | Stimulator, Muscle, Powered |
| Applicant | RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
| Contact | Patrick Cougill |
| Correspondent | Patrick Cougill RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-16 |
| Decision Date | 2012-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850814007012 | K112348 | 000 |
| 00850814007043 | K112348 | 000 |
| 00850814007180 | K112348 | 000 |
| 00850814007166 | K112348 | 000 |