510(k) K852077

VERSA STIM 380, MUSCLE STIMULATOR by Electro-Med Health Industries, Inc. — Product Code IPF

K852077 is an FDA 510(k) premarket notification submitted by Electro-Med Health Industries, Inc. for the device "VERSA STIM 380, MUSCLE STIMULATOR". The FDA issued a decision of SN on August 21, 1985. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Electro-Med Health Industries, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 21, 1985
Date Received
May 13, 1985
Clearance Type
Traditional
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