# Medical Devices; Retention of Three Preamendment Class III Devices in Class III
> **Food and Drug Administration** · Final rule. · Published 1998-06-30 · 63 FR 35516
## Document
- **Document number:** 98-17290
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 63 FR 35516
- **CFR reference:** 21 CFR 868
- **Publication date:** 1998-06-30
- **HHS docket:** Docket No. 94N-0418
## Abstract

The Food and Drug Administration (FDA) is retaining the following three preamendments class III devices in class III: Lung water monitor, powered vaginal muscle stimulator for therapeutic use, and stair-climbing wheelchair. The agency is taking this action because insufficient information exists to determine that special controls would provide reasonable assurance of their safety and effectiveness, and/or these devices present a potential unreasonable risk of illness or injury.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1998/06/30/98-17290/medical-devices-retention-of-three-preamendment-class-iii-devices-in-class-iii)
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