Product code ILQ
- Device name
- System, Communication, Powered
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.3710
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162817 | Noddle(TM) | Iowa Adaptive Technologies, Inc. Dba Voxello, Inc. | 2017-01-18 |
| K943035 | P.A.T. SYSTEM | Mathews Assoc., Inc. | 1994-10-04 |
| K930044 | COMFORT KEYBOARD SYSTEM | Health Care Keyboard Co., Inc. | 1994-07-14 |
| K931855 | LIGHTWRITER | Zygo Corp. | 1994-05-10 |
| K935244 | R & D BATTERIES, INC. PART NUMBER 5113 | R & D Batteries, Inc. | 1994-04-19 |
| K935981 | MLT-2 | Med Labs, Inc. | 1994-02-17 |
| K925387 | LIBERATOR | Prentke Romich Co. | 1993-03-29 |
| K925527 | LIGHT TALKER | Prentke Romich Co. | 1993-03-22 |
| K924013 | MACAW | Zygo Industries, Inc. | 1993-03-04 |
| K924014 | SECRETARY | Zygo Industries, Inc. | 1993-03-04 |
| K924015 | PARROT | Zygo Industries, Inc. | 1993-03-04 |
| K924030 | SCRIBE | Zygo Industries, Inc. | 1993-03-04 |
| K923819 | EEC-1 PACKAGE | Med Labs, Inc. | 1992-11-06 |
| K914259 | TOUCH TALKER | Prentke Romich Co. | 1992-02-27 |
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM | Lifeline Systems, Inc. | 1991-09-27 |
| K910796 | COMPANION SPEECH AID, MODEL 432 | Companion Products Intl. | 1991-03-07 |
| K910819 | COMPANION SPEECH AID, MODEL 160 | Companion Products Intl. | 1991-03-07 |
| K905474 | THE EYEGAZE SYSTEM | Lc Technologies, Inc. | 1991-02-28 |
| K905576 | LINGRAPHICA VISUAL LANGUAGE PROSTHESIS | Tolfa Corp. | 1990-12-31 |
| K904796 | MEDICAL ALERT SYSTEM, MODEL 2200 & 4400 V/T | Personal Emergency Response System | 1990-11-26 |
| K903605 | CINTEX | Nanopac, Inc. | 1990-09-14 |
| K903652 | SCAN COM AND SCAN COM P (TENTATIVE) | Med Labs, Inc. | 1990-08-24 |
| K902206 | CONTROL 1 ENVIRONMENTAL CONTROL | Prentke Romich Co. | 1990-05-29 |
| K901029 | YES-NO VOICE BOX 7011 | Baylor Biomedical Services | 1990-03-13 |
| K901030 | ROTARY COMMUNICATION SCANNER MODEL 7010 | Baylor Biomedical Services | 1990-03-13 |
| K893473 | COMMUNI-CALL | Carepartners, Inc. | 1989-06-09 |
| K864204 | VOCAID, ELECTRONIC VOCAL AID | Texas Instruments, Inc. | 1986-11-14 |
| K863995 | KEYNOTE | Sensory Aids Corp. | 1986-11-13 |
| K842535 | PENTAD VOCALIZER | Pentad Corp. | 1984-07-13 |
| K841528 | CONVAID - SPEECH AID | Convaid , Ltd. | 1984-05-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812324018322 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018513 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018506 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018490 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018483 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018476 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018469 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018452 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018445 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018438 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018421 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018407 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018315 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018339 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018346 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018353 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018360 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018377 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018384 | Series 7 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018391 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00812324018414 | Series 8 Anacom MedTek | Anacom Medtek | 2026-09-30 |
| 00887761943131 | Voalte Nurse Call | HILL-ROM, INC. | 2026-09-28 |
| 00840828197014 | RESPONDER 5, INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-08-18 |
| 00840828196901 | PAD WIRELESS, UNDER SEAT, 10"X15" | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-23 |
| 00840828196710 | P4600 90°,S4600,1 FT,R6,PS BREAKAWAY | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-08 |
| 00840828196727 | 4600,R6,BASIC,2 LT,DV | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-08 |
| 00840828196734 | 4600,R6,ENH,2 LT,DV | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-08 |
| 00840828196741 | RESPONDER 5, INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-08 |
| 00840828196765 | RESPONDER 5, INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-08 |
| 00840828196772 | RESPONDER 5, INTERACTIVE | CURBELL MEDICAL PRODUCTS, INC. | 2026-07-08 |