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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 K881051
Device Name SAFETY PLUS MODEL 501
Applicant
Safety Rehab Systems, Inc.
147 Eady Ct.
Elyria,  OH  44035
Applicant Contact ROBERT DAUGHERTY
Correspondent
Safety Rehab Systems, Inc.
147 Eady Ct.
Elyria,  OH  44035
Correspondent Contact ROBERT DAUGHERTY
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/11/1988
Decision Date 03/21/1988
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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