Cleared Traditional

EXERCISER, PASSIVE, NON MEASURING

K830560 · Kaye Products, Inc. · Physical Medicine

Mar 1983

Decision

14d

Days

Class 1

Risk

About This 510(k) Submission

K830560 is an FDA 510(k) clearance for the EXERCISER, PASSIVE, NON MEASURING, a Exerciser, Non-measuring (Class I — General Controls, product code ION), submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983, 14 days after receiving the submission on February 23, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number	K830560 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 1983
Decision Date	March 09, 1983
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—