Regulatory filing

fda_510k (us_fda)

FDA-cleared for medical use in rehabilitation. HAL detects bioelectric skin signals to assist limb movement.

fda 510k · cleared · decided 2018-01-01

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing date: 2018-01-01
Decision date: 2018-01-01
Verification posture: verified

Applicant

Covered models (1)

Cyberdyne HAL

Sources (1)

https://www.cyberdyne.jp/en/products/about-hal

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Identity

680b791b-3a5b-4fc9-9a98-fd065350efad