510(k) K960457

ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C by Med Labs, Inc. — Product Code IPF

K960457 is an FDA 510(k) premarket notification submitted by Med Labs, Inc. for the device "ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C". The FDA issued a decision of Substantially Equivalent on September 6, 1996. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Med Labs, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1996
Date Received
January 30, 1996
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