The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs-4v Muscle Stimulator.
Device ID | K990697 |
510k Number | K990697 |
Device Name: | RS-4V MUSCLE STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | RS MEDICAL P.O. BOX 4656 Vancouver, WA 98662 -0656 |
Contact | Mike Mcgraw |
Correspondent | Mike Mcgraw RS MEDICAL P.O. BOX 4656 Vancouver, WA 98662 -0656 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-03 |
Decision Date | 1999-06-18 |
Summary: | summary |