MWJ · Electrocardiograph, Ambulatory (Without Analysis)

Device class

Class II

Regulation 870.2800

Total clearances

2021-11-22 → 2026-09-11

Last 12 months

Unique sponsors

Classification details

Medical specialty

Cardiovascular

Review panel

Regulation number

870.2800

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
Biotricity	2	0	2022-07-28
Spacelabs Healthcare, Ltd.	2	0	2022-11-07
Kestra Medical Technologies, Inc.	1	0	2024-05-07
Zywie, Inc.	1	1	2026-06-18
Peerbridge Health, Inc.	1	1	2026-09-04
Schiller AG	1	1	2026-08-14
Shenzhen Xinyan Medical Technology Co.,ltd.	1	1	2026-09-11
Medicalgorithmics S.A.	1	0	2022-06-02
Heartbeam, Inc.	1	0	2024-12-13
Seers Technology Co., Ltd.	1	1	2026-06-25

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.

Code	Type	Description	Confidence	Rationale
93000	CPT	—	High	Standard CPT for 12-lead electrocardiogram (ECG) recording and interpretation
93005	CPT	—	Medium	CPT for ECG tracing only, without interpretation

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-09-11	K254119	Shenzhen Xinyan Medical Technology Co.,ltd.	Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)
2026-09-04	K253529	Peerbridge Health, Inc.	Peerbridge COR MDx (Cor MDx)
2026-08-14	K253562	Schiller AG	medilogFD
2026-06-25	K253384	Seers Technology Co., Ltd.	mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)
2026-06-18	K252839	Zywie, Inc.	ZywieZ3 Sensor & Adhesive
2024-12-13	K231424	Heartbeam, Inc.	HeartBeam AIMIGo(TM) System
2024-05-07	K233864	Kestra Medical Technologies, Inc.	ASSURE Wearable ECG
2022-11-07	K212317	Spacelabs Healthcare, Ltd.	Eclipse MINI Model 98900
2022-07-28	K222017	Biotricity	Biotres
2022-06-02	K210758	Medicalgorithmics S.A.	Q Patch
2022-01-19	K211709	Biotricity	Biotres
2021-11-22	K211651	Spacelabs Healthcare, Ltd.	Eclipse PRO