Regulatory filing

fda_510k (us_fda)

FDA 510(k) clearance for ReWalk Personal Exoskeleton. First exoskeleton cleared by FDA for personal use via clinical studies.

fda 510k · cleared · decided 2014-06-26

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Filing date: 2014-06-26
Decision date: 2014-06-26
Verification posture: verified
Cap-flag notes: First FDA-cleared personal exoskeleton.

Applicant

Covered models (1)

ReWalk Personal 6.0

Sources (1)

https://ir.rewalk.com/news-releases/news-release-details/rewalktm-personal-exoskeleton-system-cleared-fda-home-use

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Identity

bbed144c-9c52-4c3f-beaf-833388b8d1a2