Chrysalis Intelligence · Product Codes · NHI

NHI · Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Neurology · 7 clearances · 2 unique sponsors

Device class
Class II
Regulation 882.5890
Total clearances
7
2021-01-22 → 2023-01-25
Last 12 months
0
Unique sponsors
2
Definition

What is Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

Percutaneous electrical nerve stimulator (pens) is a device used for the treatment of pain. Unlike the classified transcutaneous electrical nerve stimulator that apply an electrical current to electrodes on a patient's skin to deliver stimulation, a pens uses electrodes that are placed percutaneously to deliver stimulation,
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5890
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Dyansys, Inc. 4 0 2022-09-13
Spr Therapeutics, Inc. 3 0 2023-01-25
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
64550 CPT — Medium Percutaneous nerve stimulation for pain management
E0761 HCPCS Non-thermal pulsed high frequency radiowaves, high peak power electromagnetic energy treatment device ✓ CMS-verified description Medium Percutaneous electrical nerve stimulator durable medical equipment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2023-01-25 K223306 Spr Therapeutics, Inc. SPRINT Peripheral Nerve Stimulation (PNS) System
2022-09-13 K221425 Dyansys, Inc. Primary Relief
2022-05-12 K220397 Dyansys, Inc. ANSiStim-PP
2022-01-31 K213188 Dyansys, Inc. Primary Relief
2021-12-20 K212859 Dyansys, Inc. First Relief
2021-10-13 K211801 Spr Therapeutics, Inc. SPRINT PNS System
2021-01-22 K202660 Spr Therapeutics, Inc. SPRINT PNS System