Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1526550

FEI Number

3010819851

Entity Name

PRENTKE ROMICH CO.

City/State/Country

WOOSTER, OH, US

Establishment Address

1022 Heyl Rd, WOOSTER, OH 44691, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Prentke Romich Company (Owner Number: 1526550)

Owner / Operator Contact Address

1022 Heyl Rd., --, Wooster, OH 44691, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

WCMK - Wheel chair Mounting Kit TouchChat Express Chat Fusion NovaChat VersaChat PRiO Accent Speech Generating Device (SGD) iOS Applications Via

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNO	Accessories, Wheelchair	Physical Medicine	Class 1	890.3910	2015-09-15
ILQ	System, Communication, Powered	Physical Medicine	Class 2	890.3710	1992-06-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Prentke Romich Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2016	Lifeline Systems, Incorporated	2	Philips GoSafe Mobile Help Button; 7000MHB. Personal Emergency Response System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1526550. Last updated year: 2026. Please use registration number 1526550 when referencing this establishment in official correspondence.