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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K940455
Device Name LATERAL FLEXION MACHINE
Applicant
Rehab, Inc.
P.O. Box 2106
Knoxville,  TN  37901
Applicant Contact DOUG RHEA
Correspondent
Rehab, Inc.
P.O. Box 2106
Knoxville,  TN  37901
Correspondent Contact DOUG RHEA
Regulation Number890.5380
Classification Product Code
BXB  
Date Received02/01/1994
Decision Date 01/12/1995
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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