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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 K930742
Device Name PEGASUS PROACTIVE WHEELCHAIR CUSHION
Applicant
Pegasus Airwave, Inc.
640 S. Militay Trl.
Deerfield Beach,  FL  33442
Applicant Contact WELCH
Correspondent
Pegasus Airwave, Inc.
640 S. Militay Trl.
Deerfield Beach,  FL  33442
Correspondent Contact WELCH
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/12/1993
Decision Date 03/31/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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