Cleared Traditional

K925387 - LIBERATOR
(FDA 510(k) Clearance)

K925387 · Prentke Romich Co. · Physical Medicine
Mar 1993
Decision
154d
Days
Class 2
Risk

K925387 is an FDA 510(k) clearance for the LIBERATOR, a System, Communication, Powered (Class II — Special Controls, product code ILQ), submitted by Prentke Romich Co. (Wooster, US). The FDA issued a Cleared decision on March 29, 1993, 154 days after receiving the submission on October 26, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3710.

Submission Details

510(k) Number K925387 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1992
Decision Date March 29, 1993
Days to Decision 154 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code ILQ — System, Communication, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.3710