Clearance Summary
SYSTEM5RH STATIONARY EXERCISE BICYCLE received FDA 510(k) clearance under submission number K881475, sponsored by Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1988-08-02.
- Submission: K881475
- Applicant / Sponsor: Combi Co. Ltd., C/O Mitsui & Co. U.S.A., Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2340
- Decision date: 1988-08-02
Classification & Regulation
This clearance is catalogued under FDA product code DPS and 21 CFR 870.2340, within the Cardiovascular review panel as a Class II device.