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 |
|---|---|---|---|
| 00816486021855 | Genesis™ 13 28 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021992 | Genesis™ 16 8 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021985 | Genesis™ 16 36 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021978 | Genesis™ 16 28 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021961 | Genesis™ 16 15 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021954 | Genesis™ 16 84 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021947 | Genesis™ 16 60 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021930 | Genesis™ 16 45 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021923 | Genesis™ 16 144 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021916 | Genesis™ 13 144 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021909 | Genesis™ 13 84 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021893 | Genesis™ 13 8 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021886 | Genesis™ 13 60 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021879 | Genesis™ 13 45 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021862 | Genesis™ 13 36 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021589 | Via™ Pro 11 | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021848 | Genesis™ 13 15 Location TouchGuide | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021831 | Genesis™ 13 8 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021824 | Genesis™ 13 36 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021817 | Genesis™ 13 28 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021800 | Genesis™ 13 15 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021794 | Genesis™ 13 84 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021787 | Genesis™ 13 60 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021770 | Genesis™ 13 45 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021763 | Genesis™ 13 144 Location KeyGuard | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021688 | Genesis™ 16 CHG EXT | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021671 | Genesis™ 13 CHG EXT | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021664 | Genesis Eye Tracker™ | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021619 | Genesis™ 16 | PRENTKE ROMICH COMPANY | 2026-10-21 |
| 00816486021602 | Genesis™ 13 | PRENTKE ROMICH COMPANY | 2026-10-21 |