# fda_510k (us_fda)

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

## 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

- [Lifeward](/companies/lifeward.md)

## Covered models (1)

- [ReWalk Personal 6.0](/models/rewalk-personal-6.md)

## Sources (1)

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

_Canonical URL: /regulatory-filings/rewalk-personal-6-fda-510k. HTML version: [/regulatory-filings/rewalk-personal-6-fda-510k](/regulatory-filings/rewalk-personal-6-fda-510k)._