Who else makes this device?

Name: Senti Desktop Flex (Basic Set)
Brand: Senti Desktop Flex (Basic Set)

Ear Nose & Throat › DiagnosticAudiometer

Senti Desktop Flex (Basic Set)

Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure…

Registry build 21.09.26

Senti Desktop Flex Basic Set Content: 1. Case AN100503 2. Inlay Sentiero AN100385 3. Senti Desktop Flex device AN100433 4. Headphone DD-45 AN100306 5. FW Labelprinter AN100414 6. FW Pure Tone Audiometer Class 3 AN100114 7. Bone Conductor B81 AN100888 or B71W AN100344 optionally 8. Patient response button AN100171 9. Power supply AN100524 + AN100525-USA or AN101360 + AN101251-USA optionally 10. USB data cable AN100418

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 Desktop Flex (Basic Set)
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	2020-01-20
Record revised	2023-08-03 (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 Senti Desktop Flex (Basic Set)
Catalogue number	Size	Status
100470		In distribution

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.