510(k) K791087

PORTABLE PULSE GALVANIC STIMULATOR by Staodynamics, Inc. — Product Code IPF

K791087 is an FDA 510(k) premarket notification submitted by Staodynamics, Inc. for the device "PORTABLE PULSE GALVANIC STIMULATOR". The FDA issued a decision of Substantially Equivalent on October 12, 1979. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Staodynamics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 12, 1979
Date Received
June 12, 1979
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