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 | K171909 |
| 510k Number | K171909 |
| 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 | 2017-06-26 |
| Decision Date | 2017-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04560340091091 | K171909 | 000 |
| 04560340091084 | K171909 | 000 |
| 04560340091077 | K171909 | 000 |
| 04560340091060 | K171909 | 000 |
| 04560340090971 | K171909 | 000 |
| 04560340090964 | K171909 | 000 |
| 04560340090957 | K171909 | 000 |
| 04560340090940 | K171909 | 000 |