Foot Examination Tool For Inflammatory Changes
Physical Medicine · 21 CFR 890.5050
Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. The device will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. Intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.
Recent MDR events
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Registered firms
14 firms currently registered for this product code
Ningbo Weifeng Houseware Co. Ltd
Ningbo Zhejiang, CN
Siren
San Francisco, CA, US
Mainline Medical Dental Supply
North York Ontario, CA
Celestica Dba Abelconn, Llc
Maple Grove, MN, US
Arche Healthcare
Pound Ridge, NY, US
Richardson Products, Inc.
FRANKFORT, IL, US
Orpyx Medical Technologies Inc.
Calgary Alberta, CA
Podimetrics, Inc.
Somerville, MA, US
Diabetis Jsc
Vilnius Vilniaus Apskritis, LT
Bluedrop Medical Ltd
Galway, IE
Oncore Manufacturing
Westborough, MA, US
Empo Health, Inc.
San Bruno, CA, US
Sonic Manufacturing Technologies, Inc.
Fremont, CA, US
510(k) clearances
2 clearances for this product code