Cleared Traditional

K914259 - TOUCH TALKER
(FDA 510(k) Clearance)

K914259 · Prentke Romich Co. · Physical Medicine device

Feb 1992

Decision

157d

Days

Class 2

Risk

K914259 is an FDA 510(k) clearance for the TOUCH 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 February 27, 1992, 157 days after receiving the submission on September 23, 1991.

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

Submission Details

510(k) Number	K914259 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 23, 1991
Decision Date	February 27, 1992
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement