Cleared Traditional

K830400 - MADDATRAINER HAND EXERCISER
(FDA 510(k) Clearance)

K830400 · Maddak, Inc. · Physical Medicine device

Mar 1983

Decision

30d

Days

Class 1

Risk

K830400 is an FDA 510(k) clearance for the MADDATRAINER HAND EXERCISER. This device is classified as a Exerciser, Non-measuring (Class I - General Controls, product code ION).

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983, 30 days after receiving the submission on February 7, 1983.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5370.

Submission Details

510(k) Number	K830400 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 07, 1983
Decision Date	March 09, 1983
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—