Definition: Relief / Reduction Of Mosquito Bite Itch
| Device Type ID | 3777 |
| Device Name | Piezo-electric Stimulator For Relief Of Mosquito Bite Itch |
| Physical State | The Device Is Hand-held, Composed Of An Insulated Housing Which Contains A Piezo-electric Crystal And Conductive Elements To Deliver Charge To The Skin, As Well As A Moving Mechanical Part To Allow The Intended User To Generate The Force To Produce T |
| Technical Method | Electrical Charge, Generated Via Piezo-electric Crystal, Delivered Transcutaneously At The Site Of The Mosquito Bite. The Piezo-electric Crystal Generates Electrical Charge By The Application Of A Manual Mechanical Force. |
| Target Area | Intended To Be Placed On The Skin, At The Site Of A Mosquito Bite. |
| Regulation Description | Limited Output Transcutaneous Piezoelectric Stimulator For Skin Reactions Associated With Insect Bites. |
| Regulation Medical Specialty | Neurology |
| 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 | 882.5894 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OSG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3777 |
| Device | Piezo-electric Stimulator For Relief Of Mosquito Bite Itch |
| Product Code | OSG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Limited Output Transcutaneous Piezoelectric Stimulator For Skin Reactions Associated With Insect Bites. |
| CFR Regulation Number | 882.5894 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ECOBRANDS LTD. | ||
GRANTED | 1 | |
TECNIMED S.R.L. | ||
GRANTED | 1 | |