Wrist Blood Pressure Monitor & Fat Meter, Model WT-20
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K031582 FDA 510(k)
- FDA Product Code
- MNW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2770 FDA 510(k)
- Regulation Number
- 870.2770 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 is a device that measures blood pressure and body composition, including body fat. It is designed for use in monitoring cardiovascular health and assessing body composition metrics.
The device is supplied as a single-use item and is intended for use in a clinical or home setting. It is not sterilized and requires proper storage conditions. The device is regulated under FDA 510(k) authorization, with a decision date of August 1, 2003.
Frequently asked questions
What does the WT-20 device measure?
The WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 is designed to measure blood pressure and assess body composition, including body fat.
Is the WT-20 device sterile?
No, the device is not sterilized and requires proper storage conditions.
Is the WT-20 intended for single use?
Yes, the device is supplied as a single-use item.
Where can the WT-20 be used?
The device is intended for use in either a clinical or home setting.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF EJ*E~Nif.ii%se~ - Food and Drug Administration, PDF K031582 Wrist Blood Pressure Monitor & Fat Meter, Model Wt-20, Technical Data | NIHON SEIMITSU SOKKI CO.,LTD.Japan, NIHON SEIMITSU SOKKI CO.,LTD.Japan | Blood pressure,Thermometer,Pulse ..., Digital Wrist Blood Pressure Monitor and Fat Meter Cat. NIS-WT-20 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031582 | Class II | Active |
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Manufacturer
- Manufacturer
- Nihon Seimitsu Sokki Co., Ltd.
Sources (1)
- FDA 510(k) K031582 24 fields · synced Oct 6, 2026