Cleared Traditional

K863728 - THE ERGOSYSTEM CHAIR
(FDA 510(k) Clearance)

K863728 · Charles D. Bell, Inc. · Ophthalmic

Oct 1986

Decision

38d

Days

Class 1

Risk

K863728 is an FDA 510(k) clearance for the THE ERGOSYSTEM CHAIR, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Charles D. Bell, Inc. (Westville, US). The FDA issued a Cleared decision on October 31, 1986, 38 days after receiving the submission on September 23, 1986. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number	K863728 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 1986
Decision Date	October 31, 1986
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—