Product code IRA
- Device name
- Hand, External Limb Component, Mechanical
- Medical specialty
- Physical Medicine
- Device class
- 1
- Regulation number
- 890.3420
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04719883463500 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | 2025-01-10 |
| 04719883463517 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | 2025-01-10 |
| 04719883463524 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | 2025-01-10 |
| 04719883463531 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | 2025-01-10 |
| 04719883463494 | TEHLIN | TEH LIN PROSTHETIC & ORTHOPAEDIC INC. | 2025-01-10 |
| 00713980004615 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980008651 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980005131 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980005148 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980005179 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980005384 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980006008 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980006015 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980006046 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980008620 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980008637 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980008644 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980004332 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001447 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001430 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001423 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001416 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001409 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001393 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001386 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001379 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001362 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001355 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001348 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |
| 00713980001331 | LOCK DEVICES | Alps South, LLC | 2024-12-30 |