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
Device Type ID | 5227 |
Device Name | Monitor, Orthotic/prosthetic |
Regulation Description | Prosthetic And Orthotic Accessory. |
Regulation Medical Specialty | Physical Medicine |
Review Panel | Physical Medicine |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 890.3025 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NHF |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5227 |
Device | Monitor, Orthotic/prosthetic |
Product Code | NHF |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Prosthetic And Orthotic Accessory. |
CFR Regulation Number | 890.3025 [🔎] |