Device Type ID | 3816 |
Device Name | Dynamometer, Ac-powered |
Regulation Description | AC-powered Dynamometer. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Neurology |
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 | 888.1240 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | LBB |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
Device Type ID | 3816 |
Device | Dynamometer, Ac-powered |
Product Code | LBB |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | AC-powered Dynamometer. |
CFR Regulation Number | 888.1240 [🔎] |