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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K010941
Device Name THE NIMBLE ROCKET POWERED WHEELCHAIR
Applicant
Nimble, Inc.
55 Northern Blvd.
Suite 200
Great Neck,  NY  10121
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Nimble, Inc.
55 Northern Blvd.
Suite 200
Great Neck,  NY  10121
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number890.3860
Classification Product Code
ITI  
Date Received03/29/2001
Decision Date 06/22/2001
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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