Who else makes this device?

Name: Sentiero Advanced
Brand: Sentiero Advanced

Neurology › DiagnosticStimulator, Auditory, Evoked Response

Sentiero Advanced

Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag…

Registry build 21.09.26

Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Headphone DD-45 AN100306 8. Probe EP-DP Path long AN100028-US 9. Accessory box Sentiero Combo AN100261 10. ABR Quick SW AN100337-Quick 11. TEOAE Quick SW AN100109-Quick 12. DPOAE Quick SW AN100110-Quick 13. FMDPOAE SW AN100536 14. Tymp Class 2 SW AN100560 15. Audio Class 4 Advanced SW AN100653 16. Mira PC Patient Management SW AN100116 17. Label Printer SW AN100414 18. Power Supply Sentiero Advanced US AN101016+AN100993-USA 19. Tympanometry add-on TY-MA AN100947 20. Accessory box AB08 AN100734-P 21. Tympanometry cavity AN100549 22. Probe tip small PT-S AN100014-W (3 pcs.) 23. Probe tip medium PT-A AN100013 (5 pcs.)

4manufacturers in China registered for this device type

14catalogue numbers in this listing

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 Sentiero Advanced
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	2020-06-27
Record revised	2022-06-30 (version 5)

Specifications

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

Catalogue Numbers

Catalogue numbers for Sentiero Advanced
Catalogue number	Size	Status
100340-SC-AD-LT		In distribution
100340-SK		In distribution
100340-SC-AT-LT		In distribution
100340-SC-ADT		In distribution
100340-SC-AT		In distribution
100340-SC-ADT-LT		In distribution
100340-SC-ALL		In distribution
100340-SC-A		In distribution
100340-SC-AD		In distribution
100340-SC-A-LT		In distribution
100340-SC-ALL-LT		In distribution
100340-US0		In distribution
100340-ED		In distribution
100340-SC		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
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
ICS	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.