Cleared Traditional

K942397 - THERADAPT HIGHCHAIR/STROLLER INSERT
(FDA 510(k) Clearance)

K942397 · Theradapt Products, Inc. · Physical Medicine

Jun 1994

Decision

34d

Days

Class 1

Risk

K942397 is an FDA 510(k) clearance for the THERADAPT HIGHCHAIR/STROLLER INSERT. This device is classified as a Chair, Adjustable, Mechanical (Class I — General Controls, product code INN).

Submitted by Theradapt Products, Inc. (Bensenville, US). The FDA issued a Cleared decision on June 22, 1994, 34 days after receiving the submission on May 19, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number	K942397 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 1994
Decision Date	June 22, 1994
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement