Clearance Summary
ACU-TRAIN V (5) received FDA 510(k) clearance under submission number K920532, sponsored by Sterne Medical Equipment Div. Ontario , Ltd.. 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 1992-07-17.
- Submission: K920532
- Applicant / Sponsor: Sterne Medical Equipment Div. Ontario , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1992-07-17
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.