ILQ · System, Communication, Powered
Physical Medicine · 21 CFR 890.3710 · Class 2
Overview
| Product Code | ILQ |
|---|---|
| Device Name | System, Communication, Powered |
| Regulation | 21 CFR 890.3710 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
A powered communication system is an AC- or battery-powered device intended for medical purposes that is used to transmit or receive information. It is used by persons unable to use normal communication methods because of physical impairment. Examples of powered communication systems include the following: a specialized typewriter, a reading machine, and a video picture and word screen.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K162817 | Noddle(TM) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | Jan 18, 2017 | SESE |
| K943035 | P.A.T. SYSTEM | Mathews Assoc., Inc. | Oct 4, 1994 | SESE |
| K930044 | COMFORT KEYBOARD SYSTEM | Health Care Keyboard Co., Inc. | Jul 14, 1994 | SESE |
| K931855 | LIGHTWRITER | Zygo Corp. | May 10, 1994 | SESE |
| K935244 | R & D BATTERIES, INC. PART NUMBER 5113 | R & D Batteries, Inc. | Apr 19, 1994 | SESE |
| K935981 | MLT-2 | Med Labs, Inc. | Feb 17, 1994 | SESE |
| K925387 | LIBERATOR | Prentke Romich Co. | Mar 29, 1993 | SESE |
| K925527 | LIGHT TALKER | Prentke Romich Co. | Mar 22, 1993 | SESE |
| K924030 | SCRIBE | Zygo Industries, Inc. | Mar 4, 1993 | SESE |
| K924015 | PARROT | Zygo Industries, Inc. | Mar 4, 1993 | SESE |
| K924014 | SECRETARY | Zygo Industries, Inc. | Mar 4, 1993 | SESE |
| K924013 | MACAW | Zygo Industries, Inc. | Mar 4, 1993 | SESE |
| K923819 | EEC-1 PACKAGE | Med Labs, Inc. | Nov 6, 1992 | SESE |
| K914259 | TOUCH TALKER | Prentke Romich Co. | Feb 27, 1992 | SESE |
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM | Lifeline Systems, Inc. | Sep 27, 1991 | SESE |
| K910819 | COMPANION SPEECH AID, MODEL 160 | Companion Products Intl. | Mar 7, 1991 | SESE |
| K910796 | COMPANION SPEECH AID, MODEL 432 | Companion Products Intl. | Mar 7, 1991 | SESE |
| K905474 | THE EYEGAZE SYSTEM | Lc Technologies, Inc. | Feb 28, 1991 | SESE |
| K905576 | LINGRAPHICA VISUAL LANGUAGE PROSTHESIS | Tolfa Corp. | Dec 31, 1990 | SESE |
| K904796 | MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T | Personal Emergency Response System | Nov 26, 1990 | SESE |
Top Applicants
- Prentke Romich Co. — 4 clearances
- Zygo Industries, Inc. — 4 clearances
- Med Labs, Inc. — 3 clearances
- Possum, Inc. — 3 clearances
- Baylor Biomedical Services — 2 clearances
