Clearance Summary
SHAPE TO FIT COMPRESSION WEAR received FDA 510(k) clearance under submission number K101906, sponsored by Tsung Hau Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2010-09-17.
- Submission: K101906
- Applicant / Sponsor: Tsung Hau Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 2010-09-17
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.