Identity
- Trade Name
- HealthGuard FDA UDI
- Generic Name
- Automatic-inflation electronic sphygmomanometer, non-portable FDA UDI
- Device Name
- self-service wellness kiosk designed to provide results for blood pressure, weight, and percent body fat. FDA UDI
- Model / Reference
- 15 FDA UDI
- Description
- self-service wellness kiosk designed to provide results for blood pressure, weight, and percent body fat. FDA UDI
Identifiers
- Catalog Number
- HG-15 FDA UDI
- Primary DI / UDI-DI
- 00860010558508 FDA UDI
- 510(k) Number
- K143108 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Automatic-inflation electronic sphygmomanometer, non-portable 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
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Automatic-inflation electronic sphygmomanometer, non-portable
HealthGuard by Futrex Tech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Automatic-inflation electronic sphygmomanometer, non-portable.
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Cleared under the same submission
K143108 also covers:
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
- Futrex Tech, Inc.
Sources (1)
- FDA UDI 91bf22ab-324b-46bb-80a5-58cf1bbdfe95 35 fields · synced May 30, 2026