| Device Type ID | 3826 |
| Device Name | Stimulator, Electro-acupuncture |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | BWK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3826 |
| Device | Stimulator, Electro-acupuncture |
| Product Code | BWK |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIEGLER GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
DYANSYS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NAVIGANT CONSULTING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PANTHEON RESEARCH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |