510(k) K112348

RS-4I MUSCLE STIMULATOR by Rs Medical — Product Code IPF

K112348 is an FDA 510(k) premarket notification submitted by Rs Medical for the device "RS-4I MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on January 19, 2012. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Rs Medical has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2012
Date Received
August 16, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type