Who else makes this device?

Name: Senti Set 3
Brand: Senti Set 3

Ear Nose & Throat › DiagnosticAudiometer

Senti Set 3

Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer…

Registry build 21.09.26

Senti Audiometry (Class 3 with HF) Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. Senti device with touchscreen AN100097 4. FW Labelprinter AN100414 5. Pure Tone Audiometer Class 3 AN100114 6. Pure Tone Audiometer High Frequency AN100454 7. Headphone HDA-300 AN100630 8. Bone conductor B-71 with Patient Response button AN100214 9. Power supply AN100083 10. USB data cable AN100089

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

All of them in Zhejiang.

Chinese manufacturers registered for FDA product code EWO
Manufacturer	City	Province	Registered as	Device types
Fastsound Acoustic Technology (Hangzhou) Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	6
Zoomax Technology Co., Limited	Hangzhou	Zhejiang	Contract manufacturer	5

Record

Regulatory record for Senti Set 3
Listed by	Path, Germany
FDA product code	EWO
Device type	Audiometer
Device class	Class 2
Regulation	21 CFR 874.1050
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2018-05-14
Record revised	2023-08-03 (version 3)

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
Distribution end date	2020-01-20

Catalogue Numbers

Catalogue numbers for Senti Set 3
Catalogue number	Size	Status
100460		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
RadioEar A/S	Interacoustics A/S	131
GN Otometrics A/S	Natus Medical Denmark ApS	88
Audiometer	Etymotic Research, Inc.	73
Siemens	WS Audiology USA, Inc.	57
Bio-logic	Natus Medical Incorporated	33
Welch Allyn, Inc.	Welch Allyn, Inc.	29
Real-EAR	WS Audiology USA, Inc.	26
Sanibel Supply A/S	Interacoustics A/S	18
Natus	Natus Medical Incorporated	14
Grason-Stadler	Diagnostic Group LLC	12
Interacoustics	Interacoustics A/S	12
Oscilla	Inmedico A/S	12

Showing 12 of 348. All products under Audiometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K213345	2022-06-22
K133012	2014-06-09

Recalls

4 of these are 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	Quantity
2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	28 units
2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	23 units
2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	15 units
2023-09-26	Class II	Process change control	Affected lots of product may experience technical distortions to a greater extent than expected.	1 unit

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.