Clearance Summary
DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006 received FDA 510(k) clearance under submission number K052309, sponsored by Saehan Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2005-09-27.
- Submission: K052309
- Applicant / Sponsor: Saehan Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1240
- Decision date: 2005-09-27
Classification & Regulation
This clearance is catalogued under FDA product code LBB and 21 CFR 888.1240, within the Orthopedic review panel as a Class II device.