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)

510(k) premarket notification. Decision: Substantially Equivalent, 11 September 2026. Product code MWJ.

Clearance

Each row is one field of the openFDA record. The grey name is the field’s name in openFDA’s documentation.

Field	Value	Field name
510(k) number	K254119	k_number
Device name	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)	device_name
Applicant	Shenzhen Xinyan Medical Technology Co.,ltd.	applicant
Decision date	2026-09-11	decision_date
Decision	Substantially Equivalent	decision
Product code	MWJ	product_code
Device class	null	device_class
Review panel	Cardiovascular	review_panel
Clearance type	Traditional	clearance_type
Statement or summary	Summary	summary_type
Regulation number	null	regulation_number
Predicate devices	null	predicate_devices

Source: FDA openFDA, device/510k, K254119, retrieved 2026-10-15 16:01 Eastern. Public domain (CC0).

Product code

The FDA classification record for the code on this record.

MWJ

Electrocardiograph, Ambulatory (Without Analysis)

Device class 2 · Regulation 870.2800 · Review panel CV

All records with this codeClassification record on FDA

ArrHub vocabulary

Electrophysiology

MWJ is one of the 60 product codes in ArrHub’s electrophysiology vocabulary, each held with its FDA classification record as its citation. Vocabulary entry verified 20 September 2026.

ArrHub

What ArrHub adds to the record. Everything above this line is the agency’s; everything here is ArrHub’s, dated and attributed.

Resolution

No verified alias in ArrHub’s table; the name stands as the register spells it.

First seen by ArrHub’s weekly snapshot: 2026-10-15 17:24 Eastern.

Raw record

The stored record exactly as ArrHub holds it, for anyone who wants to check the page against it.

Show the raw record (JSON)device/510k.json?search=k_number:K254119&limit=1

{
  "id": "301f6227-3c81-46c2-82bf-5ce5215c339b",
  "k_number": "K254119",
  "device_name": "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)",
  "applicant": "Shenzhen Xinyan Medical Technology Co.,ltd.",
  "decision_date": "2026-09-11",
  "decision": "Substantially Equivalent",
  "product_code": "MWJ",
  "device_class": null,
  "review_panel": "Cardiovascular",
  "clearance_type": "Traditional",
  "summary_type": "Summary",
  "regulation_number": null,
  "predicate_devices": null,
  "source_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254119",
  "verified_at": "2026-10-15T21:15:16.523+00:00",
  "created_at": "2026-10-15T20:01:32.685082+00:00",
  "updated_at": "2026-10-15T20:01:32.234+00:00",
  "collected_at": "2026-10-15T20:01:32.234+00:00",
  "last_checked_at": "2026-10-15T21:15:16.523+00:00"
}

The readable page is rendered from the record held in ArrHub’s verified view; the agency record at api.fda.gov governs where they differ.

Links open the agency’s own records. Unlabelled links open web pages. Links marked (JSON) open an agency’s data record, which a browser shows as plain text.

Report a broken link or a record that does not match its source: alerts@arrhub.com. Corrections are published, with their date, at arrhub.com/corrections.