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Tonguetouch Keypad and Zofcom Control System

by Zofcom, Inc. 510(k)

Active United States

510(k) K911101

Overview

The Tonguetouch Keypad and Zofcom Control System is a powered environmental control system. It is classified under the medical specialty of Physical Medicine.

This device received FDA 510(k) clearance (K911101) on April 25, 1991, and is substantially equivalent to a predicate device. It is regulated under regulation number 890.3725 and assigned product code IQA.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911101 Date25 Apr 1991ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IQA
Device Class
Class II
Regulation
21 CFR Part 890.3725
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Tonguetouch Keypad and Zofcom Control System used for?

    It is a powered environmental control system designed to assist users in managing their surroundings through tongue-operated input, classified under the medical specialty of Physical Medicine for individuals with limited mobility.

  • How is the Tonguetouch Keypad and Zofcom Control System supplied or configured?

    The system consists of a tongue-operated keypad and a control unit that interfaces with environmental devices such as lights, televisions, or beds, enabling users to operate them via discrete tongue movements.

  • Is the Tonguetouch Keypad and Zofcom Control System intended for single-use or reuse?

    The device is designed for repeated use over time; it is not a single-use product but rather a durable assistive technology system meant for long-term operation by the individual user.

  • What regulatory pathway was used for the Tonguetouch Keypad and Zofcom Control System?

    The device received FDA 510(k) clearance under submission K911101 on April 25, 1991, demonstrating substantial equivalence to a predicate device under regulation 890.3725 and product code IQA.