Cleared Traditional

K925527 - LIGHT TALKER
(FDA 510(k) Clearance)

K925527 · Prentke Romich Co. · Physical Medicine device

Mar 1993

Decision

140d

Days

Class 2

Risk

K925527 is an FDA 510(k) clearance for the LIGHT TALKER. This device is classified as 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 22, 1993, 140 days after receiving the submission on November 2, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3710.

Submission Details

510(k) Number	K925527 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 02, 1992
Decision Date	March 22, 1993
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement