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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 K951414
Device Name CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR
Applicant
Champion Mfg. Corp.
5660 State Rd. 5 N.
P.O. Box 277
Shipshewana,  IN  46565
Applicant Contact W J CHAMBERLAIN
Correspondent
Champion Mfg. Corp.
5660 State Rd. 5 N.
P.O. Box 277
Shipshewana,  IN  46565
Correspondent Contact W J CHAMBERLAIN
Regulation Number890.5975
Classification Product Code
IRO  
Date Received03/27/1995
Decision Date 08/11/1995
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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