DRG · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-01-07 → 2026-07-09

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Lifesignals, Inc.	4	1	2026-07-09
Sibel Health, Inc.	2	0	2024-06-03
Vitalconnect, Inc.	2	0	2020-04-20
Sibel, Inc.	2	0	2022-11-22
Graftworx, Inc. Dba Alio	1	0	2022-03-24
The ScottCare Corporation	1	0	2025-06-04
Elastic Care Incorporated	1	0	2022-02-03
Alio, Inc.	1	0	2023-03-17
Sigknow Biomedical Co., Ltd.	1	0	2022-06-23
Biolntellisense, Inc.	1	0	2022-12-12
Biointellisense, Inc.	1	0	2024-09-26
Vitls, Inc.	1	0	2020-06-01
Perin Health Devices, LLC	1	1	2026-01-22
Vivify Health, Inc.	1	0	2023-02-06
Ingeniars S.R.L.	1	1	2025-10-02
Ergoline GmbH	1	0	2022-07-15
Cardioline S.P.A	1	0	2023-05-15
Iorbit Digital Technologies Private Limited	1	0	2025-05-16
Philips Medical Systems	1	0	2020-04-16
VivaLNK, Inc.	1	0	2020-01-07

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	Physiological signal transmitters/receivers may support rhythm or hemodynamic monitoring
93041	CPT	—	Medium	Alternative code for rhythm-only monitoring

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-09	K261569	Lifesignals, Inc.	UbiqVue 2AYe Cardiac System (UX2253)
2026-01-22	K252984	Perin Health Devices, LLC	Perin Health System (PHD80060-2)
2025-10-02	K252440	Ingeniars S.R.L.	EasyTeleMed (2.0.2)
2025-06-04	K250259	The ScottCare Corporation	TeleRehab Aermos Cardiopulmonary Rehabilitation
2025-05-16	K243837	Iorbit Digital Technologies Private Limited	iBSM
2024-11-12	K242018	Lifesignals, Inc.	UbiqVue 2A Multi-parameter System (UX2550)
2024-09-26	K241101	Biointellisense, Inc.	BioButton System
2024-06-03	K240251	Sibel Health, Inc.	ANNE Chest
2023-08-10	K223711	Sibel Health, Inc.	ANNE One
2023-05-15	K220526	Cardioline S.P.A	HD+12, HD+15
2023-03-17	K223073	Alio, Inc.	Alio
2023-02-06	K222398	Vivify Health, Inc.	Care Team Portal
2022-12-12	K212957	Biolntellisense, Inc.	BioButton System
2022-11-22	K221530	Sibel, Inc.	ANNE Pediatric
2022-07-15	K212883	Ergoline GmbH	ers2 - ergoline Rehabilitation System
2022-06-23	K213233	Sigknow Biomedical Co., Ltd.	EZYPRO ECG Recorder (Model: UG02)
2022-03-24	K211365	Graftworx, Inc. Dba Alio	Alio Medical Remote Monitoring System
2022-02-03	K211822	Elastic Care Incorporated	LifePath Remote Patient Monitoring Platform
2021-09-14	K211305	Sibel, Inc.	ANNE One
2021-07-21	K202868	Lifesignals, Inc.	LifeSignals Multi-Parameter Remote Monitoring Platform
2020-07-15	K200690	Lifesignals, Inc.	LifeSignals ECG Remote Monitoring Patch Platform
2020-06-01	K191620	Vitls, Inc.	Vitls Platform
2020-04-20	K193343	Vitalconnect, Inc.	Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed)
2020-04-16	K192875	Philips Medical Systems	Philips Biosensor BX100
2020-02-06	K192757	Vitalconnect, Inc.	VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor bag of 20, VitalPatch 7D Biosensor bag of 20

DRG · Unclassified

Clearance volume by quarter

Top sponsors in this product code

Likely billing codes (AI-inferred · verify with billing)

Most recent 510(k) clearances