Clearance Summary
LARGE MUSCLE STRENGTH GAUGE received FDA 510(k) clearance under submission number K945630, 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 1995-05-10.
- Submission: K945630
- Applicant / Sponsor: J-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1500
- Decision date: 1995-05-10
Classification & Regulation
This clearance is catalogued under FDA product code KQX and 21 CFR 888.1500, within the Orthopedic review panel as a Class I device.