Who else makes this device?

Name: Bio-logic
Brand: Bio-logic

Neurology › DiagnosticStimulator, Auditory, Evoked Response

Bio-Logic

The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible…

Registry build 21.09.26

The Bio-logic Navigator Pro AEP system is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing disorders.

4manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

1recall

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 Bio-logic
Listed by	Natus Medical Incorporated, United States
FDA product code	GWJ
Device type	Stimulator, Auditory, Evoked Response
Device class	Class 2
Regulation	21 CFR 882.1900
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2016-12-22
Record revised	2026-01-09 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	serial number
Storage	Storage environment humidity 25 to 95 % RH; Storage environment temperature -20 to 70 °C; Handling environment humidity 25 to 95 % RH; Handling environment temperature 10 to 35 °C
Distribution end date	2026-01-07

Catalogue Numbers

Catalogue numbers for Bio-logic
Catalogue number	Size	Status
Navigator Pro		Withdrawn

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
K141446	2014-08-22
K073665	2008-01-25
K030823	2003-04-09
K013137	2001-10-16
K936039	1995-01-05

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2010-06-04	Not classified	PMA	There is insufficient evidence to support any claims for safety and efficacy on the SonaMed Clarity devices.	284 units	2011-06-22

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.