Clearance Summary
GS-220 HAND IMPAIRMENT EVALUATION SYSTEM received FDA 510(k) clearance under submission number K912526, sponsored by J-Tech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1991-09-05.
- Submission: K912526
- Applicant / Sponsor: J-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1240
- Decision date: 1991-09-05
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.