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510(k) K915230

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

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

Other clearances by Electronic Waveform Laboratory, Inc.

  • K103738 — H-WAVE (June 1, 2011)
  • K081998 — H-WAVE SPORT (July 9, 2009)
  • K873604 — E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY (April 12, 1988)
  • K862121 — E.W.L. P-TENS/H-WAVE (June 17, 1987)
  • K813601 — E.W.L. P-TENS MODEL(TENS (March 19, 1982)

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