Cleared Traditional

K812319 - THERAPY BENCH
(FDA 510(k) Clearance)

K812319 · Kaye Products, Inc. · Physical Medicine device

Aug 1981

Decision

14d

Days

Class 1

Risk

K812319 is an FDA 510(k) clearance for the THERAPY BENCH. This device is classified as a Components, Exercise (Class I - General Controls, product code IOD).

Submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981, 14 days after receiving the submission on August 17, 1981.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5350.

Submission Details

510(k) Number	K812319 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 17, 1981
Decision Date	August 31, 1981
Days to Decision	14 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—