The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs-4i Muscle Stimulator Family.
Device ID | K032652 |
510k Number | K032652 |
Device Name: | RS-4I MUSCLE STIMULATOR FAMILY |
Classification | Stimulator, Muscle, Powered |
Applicant | RS MEDICAL 14401 S.E. FIRST ST. Vancouver, WA 98684 |
Contact | Michael B Mcgraw |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-08-28 |
Decision Date | 2003-09-12 |
Summary: | summary |