The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs2mi Muscle Stimulator Family.
Device ID | K021763 |
510k Number | K021763 |
Device Name: | RS2MI MUSCLE STIMULATOR FAMILY |
Classification | Stimulator, Muscle, Powered |
Applicant | RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
Contact | Michael B Mcgraw |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2002-05-29 |
Decision Date | 2002-06-13 |
Summary: | summary |