FDA 510(k) Application Details - K211801

Device Classification Name	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief   More FDA Info for this Device
510(K) Number	K211801
Device Name	Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief
Applicant	SPR Therapeutics, Inc. 22901 Millcreek Blvd. Suite 110 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	06/10/2021
Decision Date	10/13/2021
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