Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011651103

FEI Number

3011651103

Entity Name

VIVALNK, INC.

City/State/Country

Campbell, CA, US

Establishment Address

51 EAST CAMPBELL AVE., SUITE 160, Campbell, CA 95008, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

VivaLnk Inc (Owner Number: 10049171)

Owner / Operator Contact Address

51 EAST CAMPBELL AVE., SUITE 160, Campbell, CA 95008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162137

PMA Number

N/A

All Registered Proprietary Names

Temperature Adhesive Disposable Hydrogel Adhesive Fever Scout Adhesive Hydrogel Adhesive VivaLNK Adhesive Patch VV330 Continuous ECG Platform VV330 Continuous ECG Recorder VV350 Continuous ECG Platform VV350 Continuous ECG Recorder VV360 Continuous ECG Recorder VV360 Continuous ECG Platform Fever Scout Continuos monitoring thermometer Continuos monitoring thermometer Continuos monitoring thermometer - VV200

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2018-07-23
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2020-01-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-02-02

Official Correspondent

quoi huynh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VivaLnk Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3022331717	Shenzhen Omori Biological Technology Co., Ltd.	Shenzhen city Guangdong, CN
3017643152	Dongguan CFE Electronic Co., Ltd	Dongguan Guangdong, CN
3019737388	Hangzhou VivaLNK Medical Technology Co.,LTD.	Hangzhou Zhejiang, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011651103. Last updated year: 2026. Please use registration number 3011651103 when referencing this establishment in official correspondence.