The following data is part of a premarket notification filed by Cyberdyne Inc. with the FDA for Hal For Medical Use(lower Limb Type).
| Device ID | K201559 |
| 510k Number | K201559 |
| Device Name: | HAL For Medical Use(Lower Limb Type) |
| Classification | Powered Exoskeleton |
| Applicant | Cyberdyne Inc. 2-2-1 Gakuen-Minami Tsukuba, JP 305-0818 |
| Contact | Yohei Suzuki |
| Correspondent | Yohei Suzuki Cyberdyne Inc. 2-2-1 Gakuen-Minami Tsukuba, JP 305-0818 |
| Product Code | PHL |
| CFR Regulation Number | 890.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2020-10-02 |