Device Classification Name |
Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief
More FDA Info for this Device |
510(K) Number |
K212859 |
Device Name |
Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief |
Applicant |
DyAnsys, Inc.
300, North Bayshore Boulevard
San Mateo, CA 94401 US
Other 510(k) Applications for this Company
|
Contact |
Srini Nageshwar
Other 510(k) Applications for this Contact |
Regulation Number |
882.5890
More FDA Info for this Regulation Number |
Classification Product Code |
NHI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/08/2021 |
Decision Date |
12/20/2021 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
NE - Neurology |
Review Advisory Committee |
NE - Neurology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|