Monitor, Orthotic/prosthetic
Physical Medicine · 21 CFR 890.3025
A monitor, orthotic/prosthetic is a non-invasive, battery-powered, data storage accessory device that is attached to or embedded in medical appliances such as splints, braces, orthotics, prosthetics, and wearable exercise devices, to record how often the appliance is worn, through the use of sensors that record changes in temperature, motion, skin proximity, etc.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
11 firms currently registered for this product code
Click Medical
Steamboat Springs, CO, US
Imasen Engineering Corporation
Kakamigahara Gifu, JP
Boston Brace International, Incorporated
Stoughton, MA, US
Spinal Technology, Llc
West Yarmouth, MA, US
Innovative Neurotronics Inc.
Reno, NV, US
Opos1
Waterloo, IA, US
Aether Biomedical Sp. Z O.o.
Poznan Wielkopolskie, PL
Momentum Health Inc.
Montreal Quebec, CA
Levy & Rappel
SADDLE BROOK, NJ, US
Spinal Systems, Llc
Louisville, KY, US
Comfort Products, Inc.
Croydon, PA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.