Chrysalis Intelligence · Product Codes · QGT

QGT · Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

Neurology · 6 clearances · 2 unique sponsors

Device class
Class II
Regulation 882.5899
Total clearances
6
2020-10-23 → 2025-05-14
Last 12 months
0
Unique sponsors
2
Definition

What is Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine

A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5899
Implant
N
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
Theranica Bioelectronics , Ltd. 3 0 2023-11-08
Theranica Bio-Electronics, Ltd. 3 0 2025-05-14
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
E0720 HCPCS Transcutaneous electrical nerve stimulation (tens) device, two lead, localized stimulation ✓ CMS-verified description High Transcutaneous electrical nerve stimulator; durable medical equipment code for TENS
64550 CPT — Medium Transcutaneous electrical nerve stimulation (TENS); transcutaneous nerve stimulation for headache
64551 CPT — Medium TENS initial placement; if includes electrode setup for distal stimulation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-05-14 K250405 Theranica Bio-Electronics, Ltd. Nerivio; Nerivio Infinity
2024-10-08 K241756 Theranica Bio-Electronics, Ltd. Nerivio; NerivioInfinity
2023-11-08 K232152 Theranica Bioelectronics , Ltd. NerivioInfinity
2023-02-06 K223169 Theranica Bioelectronics , Ltd. Nerivio
2021-01-22 K203181 Theranica Bioelectronics , Ltd. Nerivio, FGD000075-4.7
2020-10-23 K201824 Theranica Bio-Electronics, Ltd. Nerivio