DXH · Transmitters And Receivers, Electrocardiograph, Telephone

Device class

Class II

Regulation 870.2920

Total clearances

2020-01-17 → 2026-02-13

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.2920

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
AliveCor, Inc.	4	0	2022-05-25
Verily Life Sciences, LLC	2	0	2022-07-19
Nanowear, Inc.	2	0	2021-09-22
QT Medical, Inc.	2	0	2023-12-06
Livmor	1	0	2020-09-23
Shandong Corecare Technology Limited	1	0	2022-10-20
Measure Labs, Inc. (Dba Preemptiveai, Inc.)	1	1	2026-02-13
Heartbeam, Inc.	1	1	2025-12-08
Huinno Co., Ltd.	1	1	2025-12-05
VitalSigns Technology Co., Ltd.	1	0	2025-06-17
Ecordum, Inc.	1	0	2020-10-30
Carre Technologies, Inc.	1	1	2025-11-18

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.

Code	Type	Description	Confidence	Rationale
93040	CPT	—	Medium	Rhythm ECG, 1-3 leads; interpretation and report

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-13	K250233	Measure Labs, Inc. (Dba Preemptiveai, Inc.)	PreemptiveAI Clinical SDK
2025-12-08	K250258	Heartbeam, Inc.	HeartBeam AIMIGo with 12-L ECG Synthesis Software System
2025-12-05	K243438	Huinno Co., Ltd.	MEMO Patch M (MPT-E08R-UNC01)
2025-11-18	K243981	Carre Technologies, Inc.	Hexoskin Medical System (7100-00016)
2025-06-17	K243003	VitalSigns Technology Co., Ltd.	VitalSigns 1-Lead Holter (VSH101)
2023-12-06	K233521	QT Medical, Inc.	QT ECG (QTERD100)
2022-10-20	K222842	Shandong Corecare Technology Limited	V-Patch Cardiac Monitor
2022-09-26	K220795	QT Medical, Inc.	QT ECG
2022-07-19	K213357	Verily Life Sciences, LLC	Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor
2022-05-25	K220350	AliveCor, Inc.	KardiaMobile 6L
2021-11-30	K211668	AliveCor, Inc.	KardiaMobile Card
2021-09-22	K212160	Nanowear, Inc.	SimpleSENSE Platform
2021-06-30	K210753	AliveCor, Inc.	KardiaMobile 6L
2020-11-06	K201669	Nanowear, Inc.	SimpleSENSE
2020-10-30	K193296	Ecordum, Inc.	eCordum Cardiac Monitor (eCordum CM)
2020-09-23	K201208	Livmor	Halo AF Detection System
2020-01-24	K191406	AliveCor, Inc.	KardiaMobile, KardiaStation
2020-01-17	K192415	Verily Life Sciences, LLC	Study Watch with Irregular Pulse Monitor