Who else makes this device?

Name: Integrity VivoStim
Brand: Integrity VivoStim

Neurology › DiagnosticStimulator, Auditory, Evoked Response

Integrity VivoStim

Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) +…

Registry build 21.09.26

Sound stimulator for use as an accessory with the second generation Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL).

4manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GWJ
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Xian Friendship Medical Electronics Co., Ltd.	Xi’An	Shaanxi	Contract manufacturer	10
Dong Guan Danchen Electrical Products Ltd.	Dong Guan	Guangdong	Contract manufacturer	2
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Integrity VivoStim
Listed by	Vivosonic Inc., Canada
FDA product code	GWJ
Device type	Stimulator, Auditory, Evoked Response
Device class	Class 2
Regulation	21 CFR 882.1900
Establishment	Manufacturer
510(k)	K043396
Record published	2020-05-04

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Integrity VivoStim
Catalogue number	Size	Status
ST-800		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GN Otometrics A/S	Natus Medical Denmark ApS	117
Natus Medical	Natus Medical Incorporated	25
QScreen Set	Path	24
AccuScreen	Natus Medical Denmark ApS	20
Natus	Natus Medical Incorporated	18
Sentiero Advanced	Path	14
Algo Pro	Natus Medical Denmark ApS	9
Algo Pro	Xltek	9
Stimulator, Auditory, Evoked Response	Medtronic Xomed, Inc.	7
Algo 3i	Natus Medical Denmark ApS	5
Teoae probe tips	Otodynamics, Ltd.	5
Algo 5	Natus Medical Denmark ApS	5

Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K242954	2024-12-19
K080060	2008-04-04
K043396	2005-01-24

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.