Product code LRA
- Device name
- Hearing Aid, Tactile
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- EN
- 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 |
|---|---|---|---|
| K883853 | ETA | Sevrain-Tech, Inc. | 1988-11-17 |
| K862471 | WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER | Institute of Logopedics | 1986-09-12 |
| K851441 | TACTICON 1600 | Medecon | 1985-06-27 |
| K851655 | TEACHER TM | Monargue Intl. | 1985-06-20 |
| K843433 | KANIEVSKI SENSORY AID OR DEVICE | Spectro Industries, Inc. | 1984-11-14 |
| K831501 | TACTIL EAR | Ear Three Systems | 1983-08-26 |
| K830418 | TACTAID | Audiological Engineering Corp. | 1983-03-10 |
| K813057 | VIBRO-COM COMMUNICATOR #8827 | Sonic Systems, Inc. | 1981-12-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 50198956102635 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-06-05 |
| 50198956101355 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-06-05 |
| 10198956102637 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-06-05 |
| 10198956101357 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-06-05 |
| 10197106833261 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-12-10 |
| 50197106767564 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-10-15 |
| 10197106767566 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-10-15 |
| 50197106754649 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-09-27 |
| 10197106754641 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-09-27 |
| 50197106780853 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-09-24 |
| 10197106780855 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-09-24 |
| 50197106738939 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-08-21 |
| 10197106738931 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-08-21 |
| 10197106677438 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-05 |
| 50197106660018 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-05 |
| 10197106660010 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-07-05 |
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| 10197106604434 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-03-20 |
| 10197106583982 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-02-15 |
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| 10197106564394 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-02-02 |
| 10197106513279 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-01-23 |
| 10197106380437 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-09-07 |
| 10197106352434 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-08-30 |
| 10197106244265 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-07-17 |
| 10197106140321 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-07-06 |
| 10197106140895 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-02-13 |
| 10197106045442 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2023-01-27 |
| 10197106059043 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-12-02 |