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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 K001970
Device Name JET 1 POWERED WHEELCHAIR
Applicant
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Applicant Contact GENE KULON
Correspondent
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Correspondent Contact GENE KULON
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/28/2000
Decision Date 09/26/2000
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
Recalls CDRH Recalls
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