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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 K042612
Device Name JAZZY 600
Applicant
PRIDE MOBILITY PRODUCTS CORP.
182 SUSQUEHANNA AVE.
EXETER,  PA  18643
Applicant Contact THOMAS J SCHAPPERT
Correspondent
PRIDE MOBILITY PRODUCTS CORP.
182 SUSQUEHANNA AVE.
EXETER,  PA  18643
Correspondent Contact THOMAS J SCHAPPERT
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/24/2004
Decision Date 10/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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