Device Classification Name |
Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief
More FDA Info for this Device |
510(K) Number |
K223306 |
Device Name |
Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief |
Applicant |
SPR Therapeutics, Inc.
22901 Millcreek Blvd. Suite 500
Cleveland, OH 44122 US
Other 510(k) Applications for this Company
|
Contact |
Kathryn Stager
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 |
10/27/2022 |
Decision Date |
01/25/2023 |
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 |
|