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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K020094
Device Name EN 600-658, EN 600-666, EN 600-664, EN 600-690, EN 600-651, EN 600-663, EN 600-665 AND EN 600-670 MECHANICAL WHEELCHAIRS
Applicant
Regulatory Insight, Inc.
13 Red Fox Ln.
Littleton,  CO  80127
Applicant Contact Kevin Walls
Correspondent
Regulatory Insight, Inc.
13 Red Fox Ln.
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/11/2002
Decision Date 03/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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