510(k) K021763

RS2MI MUSCLE STIMULATOR FAMILY by Rs Medical — Product Code IPF

K021763 is an FDA 510(k) premarket notification submitted by Rs Medical for the device "RS2MI MUSCLE STIMULATOR FAMILY". The FDA issued a decision of Substantially Equivalent on June 13, 2002. 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
June 13, 2002
Date Received
May 29, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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