The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs-4m+muscle Stimulator.
Device ID | K000114 |
510k Number | K000114 |
Device Name: | RS-4M+MUSCLE STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
Contact | Joel S Faden |
Correspondent | Joel S Faden RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-14 |
Decision Date | 2000-08-10 |