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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 K852109
Device Name PENOX PERFORMER WHEELCHAIR
Applicant
Penox Technologies, Inc.
One Penox Plz., Commerce Rd.
P.O. Box 785
Pittston,  PA  18640
Applicant Contact THANA A SAVO
Correspondent
Penox Technologies, Inc.
One Penox Plz., Commerce Rd.
P.O. Box 785
Pittston,  PA  18640
Correspondent Contact THANA A SAVO
Regulation Number890.3850
Classification Product Code
IOR  
Date Received05/15/1985
Decision Date 08/22/1985
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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