Clearance Summary
ULE-2, MULE-2, HAND ACCESSORY KIT received FDA 510(k) clearance under submission number K962855, sponsored by Penny and Giles Biometrics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1996-12-11.
- Submission: K962855
- Applicant / Sponsor: Penny and Giles Biometrics , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5360
- Decision date: 1996-12-11
Classification & Regulation
This clearance is catalogued under FDA product code ISD and 21 CFR 890.5360, within the Physical Medicine review panel as a Class II device.