Clearance Summary
HANDHELD DYNAMOMETER, MODEL #160 AND #111 received FDA 510(k) clearance under submission number K861396, sponsored by Spark Instruments & Academics, 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 1986-05-02.
- Submission: K861396
- Applicant / Sponsor: Spark Instruments & Academics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.1250
- Decision date: 1986-05-02
Classification & Regulation
This clearance is catalogued under FDA product code HRW and 21 CFR 888.1250, within the Orthopedic review panel as a Class I device.