510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NHFClass I

Monitor, Orthotic/Prosthetic

21 CFR 890.3025 / Physical Medicine
FDA source (opens on fda.gov)

NHF is the FDA product code for Monitor, Orthotic/Prosthetic, a class I device type, regulated under 21 CFR 890.3025. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NHF
Device name
Monitor, Orthotic/Prosthetic
FDA definition
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.
Regulation
21 CFR 890.3025
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code