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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 K061273
Device Name 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L
Applicant
Nova Ortho-Med, Inc.
345 W. Victoria St.
Gardena,  CA  90248
Applicant Contact SUE CHEN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/08/2006
Decision Date 05/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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