Cleared Traditional

K950377 - PARKER MODEL PE
(FDA 510(k) Clearance)

K950377 · Parker Treadmill Co., Inc. · Physical Medicine device

Sep 1995

Decision

218d

Days

Class 1

Risk

K950377 is an FDA 510(k) clearance for the PARKER MODEL PE. This device is classified as a Treadmill, Powered (Class I - General Controls, product code IOL).

Submitted by Parker Treadmill Co., Inc. (Auburn, US). The FDA issued a Cleared decision on September 6, 1995, 218 days after receiving the submission on January 31, 1995.

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

Submission Details

510(k) Number	K950377 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 31, 1995
Decision Date	September 06, 1995
Days to Decision	218 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement