THE ERGOSYSTEM CHAIR

Chair, Ophthalmic, Ac-powered

CHARLES D. BELL, INC.

The following data is part of a premarket notification filed by Charles D. Bell, Inc. with the FDA for The Ergosystem Chair.

Pre-market Notification Details

Device IDK863728
510k NumberK863728
Device Name:THE ERGOSYSTEM CHAIR
ClassificationChair, Ophthalmic, Ac-powered
Applicant CHARLES D. BELL, INC. 1214 RTE 130 Westville,  NJ  08093
ContactBell, Jr
CorrespondentBell, Jr
CHARLES D. BELL, INC. 1214 RTE 130 Westville,  NJ  08093
Product CodeHME  
CFR Regulation Number886.1140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-23
Decision Date1986-10-31

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