Chrysalis Intelligence · Product Codes · MWJ

MWJ · Electrocardiograph, Ambulatory (Without Analysis)

Cardiovascular · 10 clearances · 8 unique sponsors

Device class
Class II
Regulation 870.2800
Total clearances
10
2021-11-22 → 2026-08-14
Last 12 months
3
Unique sponsors
8
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.2800
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
Spacelabs Healthcare, Ltd. 2 0 2022-11-07
Biotricity 2 0 2022-07-28
Kestra Medical Technologies, Inc. 1 0 2024-05-07
Seers Technology Co., Ltd. 1 1 2026-06-25
Zywie, Inc. 1 1 2026-06-18
Medicalgorithmics S.A. 1 0 2022-06-02
Heartbeam, Inc. 1 0 2024-12-13
Schiller AG 1 1 2026-08-14
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
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

DateK-numberSponsorDevice
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