# Device, Impotence, Mechanical/Hydraulic
> **Product code: FHW** · Class III — High Risk (PMA approval required, life-sustaining) · Gastroenterology, Urology · 21 CFR 876.3350
## Classification
- **FDA Product Code:** FHW
- **Device class:** Class III — High Risk (PMA approval required, life-sustaining)
- **Regulation:** 21 CFR 876.3350
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 2
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

PMAs to be filed by 7/11/00 (65 FR 19658 (4/12/00))

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 5
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=FHW)
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