Cleared Traditional

K942618 - ANKLE CALF EXERCISER
(FDA 510(k) Clearance)

K942618 · Prevent Products, Inc. · Physical Medicine device

Jun 1994

Decision

64d

Days

Class 1

Risk

K942618 is an FDA 510(k) clearance for the ANKLE CALF EXERCISER. This device is classified as a Exerciser, Powered (Class I - General Controls, product code BXB).

Submitted by Prevent Products, Inc. (W St Paul, US). The FDA issued a Cleared decision on June 22, 1994, 64 days after receiving the submission on April 19, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K942618 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 19, 1994
Decision Date	June 22, 1994
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement