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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vibrator, Therapeutic
510(k) Number K955160
Device Name COMFORT, MUSCLE, CORDLESS MASSAGER, BATTERY POWERED OPERATED MASSAGER
Applicant
Everapex Design & Marketing Corp.
4th Floor , # 272, Sec. 4,
Cheng-Teh Rd.
Taipei,  TW
Applicant Contact PETER LIAO
Correspondent
Everapex Design & Marketing Corp.
4th Floor , # 272, Sec. 4,
Cheng-Teh Rd.
Taipei,  TW
Correspondent Contact PETER LIAO
Regulation Number890.5975
Classification Product Code
IRO  
Date Received11/13/1995
Decision Date 02/08/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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