ILQ
38 FDA 510(k) clearances · Product code
37 daysmedian time to decision
205 days90th percentile
38clearances measured
FDA profile
- Official device name
- System, Communication, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3710
- Medical specialty
- Physical Medicine
- Adverse events (MAUDE)
- 2014: 12 · 2022: 27 · 2023: 74 · 2024: 105 · 2025: 248 · 2026: 117
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Noddle(TM) (K162817) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | 2017-01-18 |
| P.A.T. SYSTEM (K943035) | Mathews Assoc., Inc. | 1994-10-04 |
| COMFORT KEYBOARD SYSTEM (K930044) | Health Care Keyboard Co., Inc. | 1994-07-14 |
| LIGHTWRITER (K931855) | Zygo Corp. | 1994-05-10 |
| R & D BATTERIES, INC. PART NUMBER 5113 (K935244) | R & D Batteries, Inc. | 1994-04-19 |
| MLT-2 (K935981) | Med Labs, Inc. | 1994-02-17 |
| LIBERATOR (K925387) | Prentke Romich Co. | 1993-03-29 |
| LIGHT TALKER (K925527) | Prentke Romich Co. | 1993-03-22 |
| SCRIBE (K924030) | Zygo Industries, Inc. | 1993-03-04 |
| SECRETARY (K924014) | Zygo Industries, Inc. | 1993-03-04 |
| PARROT (K924015) | Zygo Industries, Inc. | 1993-03-04 |
| MACAW (K924013) | Zygo Industries, Inc. | 1993-03-04 |
| EEC-1 PACKAGE (K923819) | Med Labs, Inc. | 1992-11-06 |
| TOUCH TALKER (K914259) | Prentke Romich Co. | 1992-02-27 |
| LIFELINE(R) PERSONAL RESPONSE SYSTEM (K914103) | Lifeline Systems, Inc. | 1991-09-27 |
| COMPANION SPEECH AID, MODEL 432 (K910796) | Companion Products Intl. | 1991-03-07 |
| COMPANION SPEECH AID, MODEL 160 (K910819) | Companion Products Intl. | 1991-03-07 |
| THE EYEGAZE SYSTEM (K905474) | Lc Technologies, Inc. | 1991-02-28 |
| LINGRAPHICA VISUAL LANGUAGE PROSTHESIS (K905576) | Tolfa Corp. | 1990-12-31 |
| MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T (K904796) | Personal Emergency Response System | 1990-11-26 |
| CINTEX (K903605) | Nanopac, Inc. | 1990-09-14 |
| SCAN COM AND SCAN COM P (TENTATIVE) (K903652) | Med Labs, Inc. | 1990-08-24 |
| CONTROL 1 ENVIRONMENTAL CONTROL (K902206) | Prentke Romich Co. | 1990-05-29 |
| ROTARY COMMUNICATION SCANNER MODEL 7010 (K901030) | Baylor Biomedical Services | 1990-03-13 |
| YES-NO VOICE BOX 7011 (K901029) | Baylor Biomedical Services | 1990-03-13 |
| COMMUNI-CALL (K893473) | Carepartners, Inc. | 1989-06-09 |
| VOCAID, ELECTRONIC VOCAL AID (K864204) | Texas Instruments, Inc. | 1986-11-14 |
| KEYNOTE (K863995) | Sensory Aids Corp. | 1986-11-13 |
| PENTAD VOCALIZER (K842535) | Pentad Corp. | 1984-07-13 |
| CONVAID - SPEECH AID (K841528) | Convaid , Ltd. | 1984-05-09 |
| APELLO, PERSONAL HEALTH SUPPORT SYS. (K831093) | Almicro Electronics, Inc. | 1983-05-16 |
| THE COMMUNICATOR (K821677) | Robert Swinney. , Ltd. | 1982-06-22 |
| BODAI PATIENT COMMUNICATOR (K812720) | Sontek Industries, Inc. | 1981-11-05 |
| SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS (K802687) | Intelligent Software Systems, Inc. | 1981-02-04 |
| CARBA LINGUARDUC (K771825) | C.R. Bard, Inc. | 1977-10-06 |
| ALARM INTERCOM DOOR LOCK (K770031) | Possum, Inc. | 1977-01-12 |
| ALARM, COMMUN.-SEC. INDEP.-EMER. (K770030) | Possum, Inc. | 1977-01-12 |
| TYPEWRITER CONTROL SYSTEMS (K770029) | Possum, Inc. | 1977-01-12 |
Track ILQ automatically
Every clearance here is in the API, with alerts when new ones post.