Data / Medical devices / China / Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
Shenzhen BelterHealthMeasurementAndAnalysisTechnologyCo.,Ltd is registered with the FDA (registration 3010288146) in Shenzhen Guangdong, China. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 18, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010288146
- Address
- 702/704,BlockC,Tsinghua Unis Science Park, No.13 Langshan Rd Hi-Tech Industrial Park(north), Nanshan District, Shenzhen Guangdong, China, 518057
- Owner or operator
- Shenzhen BelterHealthMeasurementAndAnalysisTechnology CoLtd (10043131)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- January 27, 2013
- Registered through
- 2026
- Brand names listed
- BLOOD PRESSURE MONITOR, ePA-08B4,EOC-SBPBT-L, Bathroom Scale, EF-651B4,EF-654B4,EF-655B4,EF-670B4,EF-706B4,EF-802B4,EF-803B4, Bathroom Scale,EF-804B4,EF-805B4,EF-806B4,EF-807B4,EF-914B4,EF-915B4,EF-916B4,EF-917B4, Blood Pressure Meter, ePA-46B, PA-46, PA-52, PA-54, IVBPA, T9201,BP2,ePA-13B4, PA-09, ePA-09B4, Body Composition Scale, S-, Body Composition Scale, S-3, Body Fat Scale, SF-371, Koogeek-S1, WW701Y, WW303Y, T9140, T9143, Body Fat Scale,eF-671B4, WW701YF, WW390YF, GN-WA005-199,WW390F,WW390XF,K90, eF-707B4, K70 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition | MNW | 2 | Manufacturer | accessdata.fda.gov |
| Analyzer, Body Composition, Exempt | PUH | 2 | Manufacturer | accessdata.fda.gov |
| Computer, Diagnostic, Programmable | DQK | 2 | Manufacturer | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Manufacturer | accessdata.fda.gov |
| Dispenser, Solid Medication | NXB | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 18, 2019 | K191430 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Yimi Life-Technology Co., Ltd. | accessdata.fda.gov |
| August 21, 2014 | K140681 | BELTER INFRA-RED EAR THERMOMETER | FLL | Substantially Equivalent | Shenzhen Belter Health Measurement and Analysis TE | accessdata.fda.gov |
| July 25, 2014 | K134029 | BELTER BLOOD PRESSURE METER | DXN | Substantially Equivalent | Shenzhen Belter Health Measurement and Analysis TE | accessdata.fda.gov |
| January 4, 2013 | K122976 | BODY FAT SCALE MODEL SF-371 | MNW | Substantially Equivalent | Shenzhen Belter Health Measurement and Analysis TE | accessdata.fda.gov |
| November 2, 2007 | K072919 | VENDYS, MODEL 6000 B B/C | DQK | Substantially Equivalent | Endothelix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Dispenser, Solid Medication
- All makers of Computer, Diagnostic, Programmable
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter
- All makers of Analyzer, Body Composition
Updated October 18, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.