# K200848: Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit

- Pathway: 510(k) (Traditional)
- Applicant: Micron Medical Corporation
- Decided: Aug 14, 2020 after 136 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: 7 generations back to K883780 (1988). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171366: Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG Accessory Kit, Charger Kit, Stimwave Technologies Inc., Dba Stimq, LLC (2017) Summary page 4.
- K141399: Freedom Spinal Cord Stimulator (SCS) System, Stimwave Technologies Incorporated (2014) Summary page 4.

## Indications for use
Moventis PNS is indicated for pain management in adults who have severe intrnctable 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 Moventis PNS is not intended to treat pain in the craniofacial region.

Source page: https://510kreport.com/device/K200848
Methodology: https://510kreport.com/methodology