Medical HAL Lower Limb Type (HAL-ML)
Cyberdyne, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014209138 | 3014209138 | CYBERDYNE USA INC. | 1 | Y | 2026-01-01 | 4660 La Jolla Village Drive Suites 100 & 200 Office #234 San Diego CA US 92122 |
| 3014209670 | 3014209670 | CYBERDYNE INC. | 1 | N | 2026-01-01 | 2-2-1 Gakuen-minami Tsukuba Ibaraki JP 305-0818 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 215464 | 1565814228 | K233695 | Medical HAL Lower Limb Type (HAL-ML) | PHL | 2024-05-07 |
| 215464 | 1534108159 | K201559 | HAL for Medical Use(Lower Limb type) | PHL | 2020-10-02 |
| 215464 | 1687919402 | K171909 | HAL for Medical Use (Lower Limb Type) | PHL | 2017-12-17 |
| 215464 | 1050163635 | ||||
| 215464 | 1157126780 | ||||
| 215464 | 1746754855 | ||||
| 215464 | 1746824880 | ||||
| 215464 | 1845226877 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PHL | 3 | 2024-05-07 |
Cyberdyne, Inc.
Cyberdyne Inc.
CYBERDYNE Inc.
2026-04-22
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