# System, Water Purification, General Medical Use
> **Product code: NHV** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5665
## Classification
- **FDA Product Code:** NHV
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.5665
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

The device is a portable water treatment system which features components and technology similar to water treatment systems previously cleared for hemodialysis.  The difference lies with the intended use, as the proposed device is not intended for use in hemodialysis applications, for which a product code currently exists.  Instead, the proposed device is intended for use to purify water for general purposes, including washing of surgeons hands, surgical instruments, and wound cleansing.

## Market data
- **Cleared 510(k) submissions:** 11
- **Registered establishments:** 15
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NHV)
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