Device Type ID | 3848 |
Device Name | Device, Acupressure |
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) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | MVV |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3848 |
Device | Device, Acupressure |
Product Code | MVV |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
PRESSURE POINT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |