510(k) K915230

H WAVE MUSCLE STIMULATOR by Electronic Waveform Laboratory, Inc. — Product Code IPF

K915230 is an FDA 510(k) premarket notification submitted by Electronic Waveform Laboratory, Inc. for the device "H WAVE MUSCLE STIMULATOR". The FDA issued a decision of Substantially Equivalent on May 8, 1992. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Electronic Waveform Laboratory, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1992
Date Received
November 20, 1991
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