| Device Type ID | 3746 |
| Device Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| 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) |
| CFR Regulation Number | 882.5890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3746 |
| Device | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Product Code | NFO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| CFR Regulation Number | 882.5890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BENTLEY BIOMEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CAROL COLE COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO CURRENT TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NUTRA LUXE MD, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRETIKA CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN SIKEN 3D TECHNOLOGY DEVELOPMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TAMA RESEARCH CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TROPHY SKIN, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Insufficient Information | 1 |
| Total Device Problems | 3 |