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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K891871
Device Name PHASER (SINGLE LINEAR MECHANICAL MASSAGE)
Applicant
Monad Corp.
908 E. Holt Ave.
Pomona,  CA  91767
Applicant Contact CAROL FREASIER
Correspondent
Monad Corp.
908 E. Holt Ave.
Pomona,  CA  91767
Correspondent Contact CAROL FREASIER
Regulation Number890.5660
Classification Product Code
ISA  
Date Received03/27/1989
Decision Date 04/25/1989
Decision Substantially Equivalent (SESE)
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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