Who else makes this device?

Name: Accessory Box AB08
Brand: Accessory Box AB08

Neurology › DiagnosticStimulator, Auditory, Evoked Response

Accessory Box AB08

Accessory box Content: 1. Box. AN101329 2. Ear Tip PM007H 7 mm mushroom. AN100765-PH 3. Ear Tip PM009H 9 mm mushroom. AN100767-PH 4. Ear Tip PM010H 10 mm mushroom. AN100768-PH 5. Ear Tip…

Registry build 21.09.26

Accessory box Content: 1. Box. AN101329 2. Ear Tip PM007H 7 mm mushroom. AN100765-PH 3. Ear Tip PM009H 9 mm mushroom. AN100767-PH 4. Ear Tip PM010H 10 mm mushroom. AN100768-PH 5. Ear Tip PM011H 11 mm mushroom. AN100769-PH 6. Ear Tip PM012H 12 mm mushroom. AN100770-PH 7. Ear Tip PM013H 13 mm mushroom. AN100771-PH 8. Ear Tip PM014H 14 mm mushroom. AN100772-PH 9. Ear Tip PM016H 16 mm mushroom. AN100773-PH 10. Ear Tip PM018H 18 mm mushroom. AN100774-PH

4manufacturers in China registered for this device type

1catalogue number

4510(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 Accessory Box AB08
Listed by	Path, Germany
FDA product code	GWJ
Device type	Stimulator, Auditory, Evoked Response
Device class	Class 2
Regulation	21 CFR 882.1900
Establishment	Manufacturer
Record published	2022-01-17
Record revised	2024-05-23 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date

Catalogue Numbers

Catalogue numbers for Accessory Box AB08
Catalogue number	Size	Status
100734-P		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
K220139	2022-08-03
K211147	2021-10-14
K131141	2013-06-27
K100661	2010-07-01

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. 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
2025-11-06	Class II	Component change control	Following a component change in the DPOAE probe (speaker replacement), technical distortions may occur at high stimulus levels combined with unusually low OAE amplitude acceptance thresholds. These distortions can mimic true DPOAE responses

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.