Definition: An External Upper Limb Tremor Stimulator Is A Prescription Device Which Is Placed Externally On The Upper Limb And Designed To Aid In Tremor Symptom Relief Of The Upper Limb.
Device Type ID | 3806 |
Device Name | External Upper Limb Tremor Stimulator |
Physical State | Stimulator And Wrist Band |
Technical Method | External Electrical Stimulator |
Target Area | Wrist |
Regulation Medical Specialty | Neurology |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Neurology Branch (NSDN) |
Submission Type | 510(k) |
CFR Regulation Number | 882.5897 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | QBC |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3806 |
Device | External Upper Limb Tremor Stimulator |
Product Code | QBC |
FDA Device Classification | Class 2 Medical Device |
CFR Regulation Number | 882.5897 [🔎] |