Cleared Traditional

MEDTRONIC(R) ORTHOFLEX(TM)

K874884 · Metronic, Inc. · Physical Medicine

Jan 1988

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K874884 is an FDA 510(k) clearance for the MEDTRONIC(R) ORTHOFLEX(TM), a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Metronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 28, 1988, 58 days after receiving the submission on December 1, 1987. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K874884 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 1987
Decision Date	January 28, 1988
Days to Decision	58 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	—