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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Wheelchair, Standup
510(k) Number K920463
Device Name ZIPPIE 3 TS/SP WHEELCHAIR/STANDER
Applicant
Sunrise Medical Quickie Designs, Inc.
147 Eady Ct.
Elyria,  OH  44035
Applicant Contact ROBERT WHELAND
Correspondent
Sunrise Medical Quickie Designs, Inc.
147 Eady Ct.
Elyria,  OH  44035
Correspondent Contact ROBERT WHELAND
Regulation Number890.3900
Classification Product Code
IPL  
Date Received01/27/1992
Decision Date 04/02/1992
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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