Data / Medical devices / United States / Vivalnk, Inc.

Vivalnk, Inc.: FDA-registered device maker in Campbell, CA, United States, 6 510(k) clearances

Name: Vivalnk, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vivalnk, Inc. is registered with the FDA (registration 3011651103) in Campbell, CA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 20, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3011651103
Address: 51 East Campbell Ave., Suite 160, Campbell, CA, United States, 95008
Owner or operator: VivaLnk Inc (10049171)
Roles: Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: February 2, 2017
Registered through: 2026
Brand names listed: Checkme O2/SpO2oxiband sleepmonitor, Continuos monitoring thermometer, Continuos monitoring thermometer - VV200, Disposable Hydrogel Adhesive, Electronic Blood pressure monitor cuff BP5S, Fever Scout Adhesive, Fever Scout Continuos monitoring thermometer, Hydrogel Adhesive and more

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Oximeter	DQA	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer, Specification developer	accessdata.fda.gov
Transmitters And Receivers, Physiological Signal, Radiofrequency	DRG	2	Manufacturer, Specification developer	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
December 20, 2022	K221039	Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y	FLL	Substantially Equivalent	Shenzhen AOJ Medical Technology Co., Ltd.	accessdata.fda.gov
November 8, 2022	K203812	Oxyfit Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov
January 7, 2020	K191870	VV330 Continuous ECG Platform, VivaLNK Adhesive Patch	DRG	Substantially Equivalent	VivaLNK, Inc.	accessdata.fda.gov
December 2, 2019	K191088	Checkme O2 Pulse Oximeter	DQA	Substantially Equivalent	Shenzhen Viatom Technology Co., Ltd.	accessdata.fda.gov
August 1, 2017	K171062	BP5S Wireless Blood Pressure Monitor	DXN	Substantially Equivalent	Andon Health Co, Ltd.	accessdata.fda.gov
January 19, 2017	K162137	Fever Scout Continuous Monitoring thermometer	FLL	Substantially Equivalent	VivaLNK, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 20, 2022. 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.