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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Physical Therapy, Multi Function
510(k) Number K945954
Device Name MODELS 4100 AND 4300 MULTITHERAPY
Applicant
Spinalight, Inc.
320 A Bell Park Dr.
Woodstock,  GA  30188
Applicant Contact T A COX
Correspondent
Spinalight, Inc.
320 A Bell Park Dr.
Woodstock,  GA  30188
Correspondent Contact T A COX
Regulation Number890.5880
Classification Product Code
JFB  
Date Received12/06/1994
Decision Date 01/19/1995
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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