Clearance Summary
PNEU-WAVE received FDA 510(k) clearance under submission number K911574, sponsored by Pneu-Mobility, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1991-10-02.
- Submission: K911574
- Applicant / Sponsor: Pneu-Mobility, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5880
- Decision date: 1991-10-02
Classification & Regulation
This clearance is catalogued under FDA product code JFB and 21 CFR 890.5880, within the Physical Medicine review panel as a Class II device.