Clearance Summary
VITALON MASSAGER received FDA 510(k) clearance under submission number K874843, 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 1988-01-20.
- Submission: K874843
- 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: 1988-01-20
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.