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510(k) K103738

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2011
Date Received
December 22, 2010
Clearance Type
Special
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.

  • K081998 — H-WAVE SPORT (July 9, 2009)
  • K915230 — H WAVE MUSCLE STIMULATOR (May 8, 1992)
  • 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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