Blood Pressure Monitor (W06LT)— 510(k) K253570
Substantially EquivalentShenzhen Jamr Technology Co., Ltd.
FDA 510(k) clearance K253570 for Blood Pressure Monitor (W06LT), Substantially Equivalent on 2026-05-20. Applicant: Shenzhen Jamr Technology Co., Ltd.. Device class: 2.
Summary
Shenzhen Jamr Technology's Blood Pressure Monitor (W06LT) is filed under DXN, non-invasive blood pressure measurement systems. Apart from the model number, the name is generic.
Class II, 21 CFR 870.1130. Cardiovascular is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Jamr filed from Shenzhen, China. The decision came 184 calendar days after receipt (November 17, 2025 to May 20, 2026).
Clearance details
- Applicant
- Shenzhen Jamr Technology Co., Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shenzhen, CN
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Shenzhen Jamr Technology Co., Ltd.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.