Cleared Traditional

KAYE SCOOT-ABOUT, MODEL SB1

K924848 · Kaye Products, Inc. · Physical Medicine
Feb 1993
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K924848 is an FDA 510(k) clearance for the KAYE SCOOT-ABOUT, MODEL SB1, a Chair, With Casters (Class I — General Controls, product code INM), submitted by Kaye Products, Inc. (Hillsborough, US). The FDA issued a Cleared decision on February 12, 1993, 137 days after receiving the submission on September 28, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K924848 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1992
Decision Date February 12, 1993
Days to Decision 137 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INM — Chair, With Casters
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3100