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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Finger, Powered
510(k) Number K844033
Device Name MOBILIMB HAND UNIT
Applicant
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
Danninger Medical Technology, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number890.5410
Classification Product Code
JFA  
Date Received10/15/1984
Decision Date 11/27/1984
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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