Cleared Traditional

FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE

K926262 · Sgarlato Laboratories, Inc. · Physical Medicine

Jan 1994

Decision

404d

Days

Class 1

Risk

About This 510(k) Submission

K926262 is an FDA 510(k) clearance for the FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE, a Exerciser, Powered (Class I — General Controls, product code BXB), submitted by Sgarlato Laboratories, Inc. (San Jose, US). The FDA issued a Cleared decision on January 26, 1994, 404 days after receiving the submission on December 18, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5380.

Submission Details

510(k) Number	K926262 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 1992
Decision Date	January 26, 1994
Days to Decision	404 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement