Identity
- Trade Name
- AILE Electronic Sphygmomanometers FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
- Device Name
- Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home. FDA UDI
- Model / Reference
- X8 FDA UDI
- Description
- Electronic Sphygmomanometers is intended to measure the systolic and diastolic blood pressure as well as the pulse rate of adult person and adolescents age 18 through 21 years of age .It can be used at medical facilities or at home. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972480913047 FDA UDI
- 510(k) Number
- K221040 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
AILE Electronic Sphygmomanometers by Jiangxi Aicare Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.
- Arm Type Automatic Blood Pressure Monitor — Shenzhen Jiacom Technology Co., Ltd · Class II
- Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System — DARIOHEALTH CORP. · Class II
- MoDash — Shenzhen Urion Technology Co., Ltd. · Class II
- Veridian Healthcare — VERIDIAN HEALTHCARE · Class II
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- BRIGHT LIFE — Shenzhen Urion Technology Co., Ltd. · Class II
- RemoteCare 4U — Guangdong Transtek Medical Electronics Co., Ltd · Class II
- Omron 3 Series Upper Arm Blood Pressure Monitor — Omron Healthcare, Inc. · Class II
Cleared under the same submission
K221040 also covers:
- AILE Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
- AILE Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
- AILE Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
- AILE Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
- AILE Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
- AILE Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
- COOCEER Electronic Sphygmomanometers — Jiangxi Aicare Medical Technology Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Jiangxi Aicare Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 232f64d2-2ebe-4d2f-a914-88d4a1dc4939 34 fields · synced Jun 6, 2026