Clearance Summary
TM-400 received FDA 510(k) clearance under submission number K081247, sponsored by Ito 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 2008-08-25.
- Submission: K081247
- Applicant / Sponsor: Ito Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 2008-08-25
Classification & Regulation
This clearance is catalogued under FDA product code ITH and 21 CFR 890.5900, within the Physical Medicine review panel as a Class II device.