Clearance Summary
VITALON MATRESS MASSAGE MODEL M-MX received FDA 510(k) clearance under submission number K890923, sponsored by Nexus Co. , Ltd. C/O Yama Trans Co. , 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 1989-03-14.
- Submission: K890923
- Applicant / Sponsor: Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1989-03-14
Classification & Regulation
This clearance is catalogued under FDA product code ISA and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.