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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K003059
Device Name LASER 4SPSC340
Applicant
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Applicant Contact GENE R K ULON
Correspondent
Pride Mobility Products Corp.
182 Susquehanna Ave.
Exeter,  PA  18643
Correspondent Contact GENE R K ULON
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/02/2000
Decision Date 03/01/2001
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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