# K221303: Neuspera Nuity System

- Pathway: 510(k) (Traditional)
- Applicant: Neuspera Medical, Inc.
- Decided: Apr 11, 2023 after 341 days
- Product code: GZF (Stimulator, Peripheral Nerve, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K883780 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202781: Neuspera Neurostimulation System (NNS), Neuspera Medical, Inc. (2021) Summary page 4.

## Indications for use
The Neuspera NuityTM System (NNS) is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The Neuspera NuityTM System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.

Source page: https://510kreport.com/device/K221303
Methodology: https://510kreport.com/methodology