Chrysalis Intelligence · Product Codes · QCI

QCI · Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

Neurology · 8 clearances · 6 unique sponsors

Device class
Class II
Regulation 882.5802
Total clearances
8
2020-08-09 → 2026-06-03
Last 12 months
1
Unique sponsors
6
Definition

What is Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).
Medical specialty
Neurology
Review panel
NE
Regulation number
882.5802
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
Teleemg, LLC 2 0 2023-12-22
Neuronetics 2 0 2023-06-08
Brain Ultimate, Inc. 1 0 2025-04-17
Tonica Elektronik A/S 1 0 2020-08-09
BTL Industries, Inc. 1 0 2024-02-01
Wave Neuroscience 1 1 2026-06-03
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
90867 CPT High Transcranial magnetic stimulation (TMS); treatment of OCD and psychiatric conditions
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-03 K260402 Wave Neuroscience MeRT System
2025-04-17 K243459 Brain Ultimate, Inc. Ultimate rTMS for OCD (M-series)
2024-02-01 K230657 BTL Industries, Inc. BTL-99-OC
2023-12-22 K233742 Teleemg, LLC CloudTMS Edge for OCD
2023-06-08 K231350 Neuronetics OCD MT Cap (85-00397-000)
2023-03-10 K221129 Teleemg, LLC CloudTMS for OCD
2022-05-06 K212289 Neuronetics, Inc. NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar
2020-08-09 K193006 Tonica Elektronik A/S MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system