Chrysalis Intelligence · Product Codes · QGL

QGL · Transcutaneous Nerve Stimulator For Adhd

Neurology · 4 clearances · 3 unique sponsors

Device class
Class II
Regulation 882.5898
Total clearances
4
2023-02-12 → 2025-01-16
Last 12 months
0
Unique sponsors
3
Definition

What is Transcutaneous Nerve Stimulator For Adhd

A transcutaneous electrical nerve stimulator for Attention Deficit Hyperactivity Disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5898
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
Nu Eyne Co., Ltd. 2 0 2025-01-16
Bistos Co., Ltd. 1 0 2024-08-28
Neurosigma, Inc. 1 0 2024-01-16
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; standard durable medical equipment code for TENS devices
64550 CPT Medium Transcutaneous electrical nerve stimulation (TENS); general code for TENS therapy
64551 CPT Medium TENS initial placement; if includes electrode setup and training
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-01-16 K243289 Nu Eyne Co., Ltd. ADDNOX (BPSPM1)
2024-08-28 K232991 Bistos Co., Ltd. BT-1000
2024-01-16 K233293 Neurosigma, Inc. Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®
2023-02-12 K213629 Nu Eyne Co., Ltd. SMILE