Cleared Traditional

BARS, PARALLEL, EXERCISE

K830466 · Kaye Products, Inc. · Physical Medicine

Mar 1983

Decision

22d

Days

Class 1

Risk

About This 510(k) Submission

K830466 is an FDA 510(k) clearance for the BARS, PARALLEL, EXERCISE, a Bars, Parallel, Exercise (Class I — General Controls, product code IOE), submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983, 22 days after receiving the submission on February 15, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number	K830466 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 1983
Decision Date	March 09, 1983
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—