De Novo grant
REWALK
Argo Medical Technologies, Inc. · 26 June 2014 · DEN130034
- Decision
- Unknown
- Decision date
- 26 June 2014
- Application received
- 17 June 2013
- Company
- Argo Medical Technologies, Inc.
- Device type
- Powered exoskeletons (PHL)
What it means
A De Novo grant clears a new kind of low-to-moderate-risk device that has nothing similar already on the market. Later devices of the same kind can then be cleared by comparison with it. See De Novo, explained.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.