Cleared Traditional

KAYE MODEL KIAO PELVIC/THIGH STABILIZER

K923095 · Kaye Products, Inc. · Physical Medicine
Jul 1992
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K923095 is an FDA 510(k) clearance for the KAYE MODEL KIAO PELVIC/THIGH STABILIZER, a Chair, Adjustable, Mechanical (Class I — General Controls, product code INN), submitted by Kaye Products, Inc. (Hillsborough, US). The FDA issued a Cleared decision on July 21, 1992, 26 days after receiving the submission on June 25, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K923095 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 1992
Decision Date July 21, 1992
Days to Decision 26 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INN — Chair, Adjustable, Mechanical
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3100

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