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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K902438
Device Name RX ROCKER WHEELCHAIR
Applicant
The RX Rocker Corp.
3541 Old Conejo Rd. #101
Newbury Park,  CA  91320
Applicant Contact MIECO EYER
Correspondent
The RX Rocker Corp.
3541 Old Conejo Rd. #101
Newbury Park,  CA  91320
Correspondent Contact MIECO EYER
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/01/1990
Decision Date 06/19/1990
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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