Cleared Traditional

TECHNA VISION, INC. ELECTRIC CHAIR

K853743 · Techna Vision · Ophthalmic

Oct 1985

Decision

41d

Days

Class 1

Risk

About This 510(k) Submission

K853743 is an FDA 510(k) clearance for the TECHNA VISION, INC. ELECTRIC CHAIR, a Chair, Ophthalmic, Ac-powered (Class I — General Controls, product code HME), submitted by Techna Vision (Santee, US). The FDA issued a Cleared decision on October 17, 1985, 41 days after receiving the submission on September 6, 1985. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1140.

Submission Details

510(k) Number	K853743 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 06, 1985
Decision Date	October 17, 1985
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—