Fastsound Acoustic Technology (Hangzhou) Co., Ltd.
Registered establishment in Hangzhou, Zhejiang, China. 6 device types.
Fastsound Acoustic Technology (Hangzhou) Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Audiometer and 4 other device types. Its earliest product listing with the FDA dates from 2025.
Registration
| Registered name | FASTSOUND ACOUSTIC TECHNOLOGY (HANGZHOU) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043139378 |
| FEI number | 3043139378 |
| Establishment type | Manufacturer |
Location
| City | Hangzhou |
|---|---|
| Province | Zhejiang |
| Address | R502, 5/F, Bldg 1, 5-1 Binwen Rd, Xixing Subdistrict, Binjiang District |
| Postal code | 310051 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Audiometer | Class 2 | Hearing Screen (Model: OS100, OS110, OS120, OS200, OS210, OS220, OS300, OS310, OS320), Audiometer (Model: AX800, AX800 Plus, AX800 Pro, AX800 Max, AX900, AX900 Plus, AX900 Pro, AX900 Max), Audiometer (Model: AX100, AX100 Plus, AX100 Pro, AX100 Max, AX200, AX200 Plus, AX200 Pro, AX200 Max, AX300, AX300 Plus), Audiometer (TESTER, AUDITORY IMPEDANCE), Audiometer (Model: AX500 Max, AX600, AX600 Plus, AX600 Pro, AX600 Max, AX700, AX700 Plus, AX700 Pro, AX700 Max), Audiometer (Model: AX300 Pro, AX300 Max, AX400, AX400 Plus, AX400 Pro, AX400 Max, AX500, AX500 Plus, AX500 Pro) | 2025 | 2 |
| Chamber, Acoustic (For Audiometric Testing) | Class 1 | Soundproof Booth | 2026 | 1 |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | Class 2 | Hearing Aid (Model:FB118D, FB119D, FB130D, FB131D, FB132D, FB133D, FB134D, FB135D, FB136D, FB137D, FB138D, FB139D), Hearing Aid (Model:FT113RW, FT114RW, FT115RW, FT116RW, FT117RW, FT118RW, FT119RW, FT130RW, FT131RW, FT132RW, FT133RW), Hearing Aid (Model:FR231UR, FR232UR, FR233UR, FR234UR, FR235UR, FR236UR, FR237UR, FR238UR FR239UR, FR250UR, FR251UR), Hearing Aid (Model:FT139R, FT150R, FT151R, FT152R, FT153R, FT154R, FT155R, FT156R, FT157R, FT158R, FT159R, FT170R), Hearing Aid (Model:FR153SD, FR154SD, FR155SD, FR156SD FR157SD, FR158SD, FR159SD, FR170SD, FR171SD, FR172SD, FR173SD), Hearing Aid (Model:FR234SDR, FR235SDR, FR236SDR, FR237SDR, FR238SDR, FR239SDR, FR250SDR, FR251SDR FR252SDR, FR253SDR) and 54 more | 2026 | 52 |
| Hearing Aid, Air-Conduction, Over The Counter | Class 1 | Electronic Dryer (Model:FED13, FED14, FED15, FED16, FED17, FED18, FED19, FED20, FED21, FED22, FED23, FED24, FED25), Electronic Dryer (Model:FED78, FED79, FED80, FED81, FED82, FED83, FED84, FED85, FED86, FED87, FED88, FED89, FED90), Electronic Dryer (Model:T67, T68, T69, T70, T71, T72, T73, T74, T75, T76, T77, T78, T79, T80, T81, T82, T83, T84, T85), Electronic Dryer (Model:FED26, FED27, FED28, FED29, FED30, FED31, FED32, FED33, FED34, FED35, FED36, FED37, FED38), Electronic Dryer (Model:FED52, FED53, FED54, FED55, FED56, FED57, FED58, FED59, FED60, FED61, FED62, FED63, FED64), Electronic Dryer (Model:T10, T11, T12, T13, T14, T15, T16, T17, T18, T19, T20, T21, T22, T23, T24, T25, T26, T27, T28) and 6 more | 2026 | 57 |
| Monitor, Bed Patient | Class 1 | Polysomnograph (Model: FPSG20), Polysomnograph (Model: FPSG08, FPSG09, FPSG10, FPSG11, FPSG12, FPSG13, FPSG14, FPSG15, FPSG16, FPSG17, FPSG18, FPSG19), Polysomnograph (Model: QL-01, QL-02, QL-03, QL-04, QL-05, QL-06, FPSG01, FPSG02, FPSG03, FPSG04, FPSG05, FPSG06, FPSG07) | 2026 | 14 |
| Otoscope | Class 1 | Otoscope (Model: FO208, FO209, FO210, FO211, FO212, FO213, FO214, FO215, FO216, FO217, FO218, FO219), Otoscope (1093, HEADSET HS3; Otoscan, Otocam 300; Specula, 3mm, cerumen, 12), Otoscope (Model: QZ200, QZ201, QZ202, QZ203, QZ204, QZ205, QZ206, QZ207, QZ208, QZ209, QZ210, QZ211, QZ212, QZ213), Otoscope (Specula, 3mm, normal, 12; Type 1076 – OTOcam 300; Type 1093 – Otoscan), Otoscope (Model: QZ114, QZ115, QZ116, QZ117, QZ118, QZ119, QZ010, QZ020, QZ030, QZ040, QZ060, QZ070, QZ080, QZ090), Otoscope (Model: QZ214, QZ215, QZ216, QZ217, QZ218, QZ219, FO100, FO101, FO102, FO103, FO104, FO105, FO106, FO107) and 3 more | 2026 | 43 |
From the Company
Published by the company on its own website, not by the FDA.
| Main products | Hearing screeners, AX300 Pro hearing aid, AX300 hearing aid, AX200 hearing aid |
|---|
Nearby Manufacturers
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.
The manufacturer named here can complete this record.