Data / Medical devices / Japan / Cyberdyne Inc.
Cyberdyne Inc.: FDA-registered device maker in Tsukuba Ibaraki, Japan, 2 510(k) clearances
Cyberdyne Inc. is registered with the FDA (registration 3014209670) in Tsukuba Ibaraki, Japan. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014209670
- Address
- 2-2-1 Gakuen-minami, Tsukuba Ibaraki, Japan, 305-0818
- Owner or operator
- CYBERDYNE Inc. (10056809)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 13, 2020
- Registered through
- 2026
- Brand names listed
- HAL for Medical Use Lower Limb Type, Medical HAL Lower Limb Type, Medical HAL Lumbar Type, Medical HAL Single Joint Type
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Joint, Elbow, External Limb Component, Powered | IRE | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Foot Drop | OHI | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Powered Exoskeleton | PHL | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2024 | K233695 | Medical HAL Lower Limb Type (HAL-ML) | PHL | Substantially Equivalent | Cyberdyne, Inc. | accessdata.fda.gov |
| October 2, 2020 | K201559 | HAL for Medical Use(Lower Limb type) | PHL | Substantially Equivalent | Cyberdyne, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Exerciser, Powered
- All makers of Device, Biofeedback
- All makers of Powered Exoskeleton
- All makers of Joint, Elbow, External Limb Component, Powered
- All makers of Orthosis, Limb Brace
- All makers of Orthosis, Foot Drop
Updated May 7, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.