FDA 510(k), K221303, Neuspera Nuity System

510(K) Number: K221303
Device Name: Neuspera Nuity System
Manufacturer: Alexander Yeh
Device Classification Name: Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Regulation Number: GZF
Classification Product Code: KXA
Date Received: 05/05/2022
Decision Date: 04/11/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

717 pages (2,772 of 3,489 original pages are fully redacted)