Chrysalis Intelligence · Product Codes · GZF

GZF · Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Neurology · 9 clearances · 6 unique sponsors

Device class
Class II
Regulation 882.5870
Total clearances
9
2020-03-27 → 2025-07-16
Last 12 months
0
Unique sponsors
6
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5870
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Bioness, Inc. 2 0 2022-02-23
Bioventus, LLC 2 0 2025-07-16
Neuspera Medical, Inc. 2 0 2023-04-11
Boston Scientific Neuromodulation 1 0 2024-08-21
Micron Medical Corporation 1 0 2020-08-14
Curonix 1 0 2024-06-20
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
64553 CPT High Percutaneous implantation of peripheral nerve stimulator; standard code for PNS device implantation
64584 CPT High Implantation or replacement of peripheral nerve stimulator pulse generator; PNS system implantation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-07-16 K243782 Bioventus, LLC StimTrial Neuromodulation System
2025-07-03 K243678 Bioventus, LLC TalisMann Neuromodulation System
2024-08-21 K232415 Boston Scientific Neuromodulation Nalu Neurostimulation System for Peripheral Nerve Stimulation
2024-06-20 K233162 Curonix Freedom Peripheral Nerve Stimulator (PNS) System
2023-04-11 K221303 Neuspera Medical, Inc. Neuspera Nuity System
2022-02-23 K211965 Bioness, Inc. StimRouter Neuromodulation System
2021-08-27 K202781 Neuspera Medical, Inc. Neuspera Neurostimulation System (NNS)
2020-08-14 K200848 Micron Medical Corporation Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit
2020-03-27 K200482 Bioness, Inc. StimRouter Neuromodulation System