Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043139378

FEI Number

3043139378

Entity Name

FASTSOUND ACOUSTIC TECHNOLOGY (HANGZHOU) CO., LTD.

City/State/Country

Hangzhou Zhejiang, CN

Establishment Address

R502, 5/F, Bldg 1, 5-1 Binwen Rd, Xixing Subdistrict, Binjiang District, Hangzhou Zhejiang 310051, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fastsound Acoustic Technology (Hangzhou) Co., Ltd. (Owner Number: 10094813)

Owner / Operator Contact Address

R502, 5/F, Bldg 1, 5-1 Binwen Rd, Xixing Subdistrict, Binjiang District, Hangzhou, CN-ZJ 310051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Polysomnograph (Model: FPSG20) Polysomnograph (Model: QL-01, QL-02, QL-03, QL-04, QL-05, QL-06, FPSG01, FPSG02, FPSG03, FPSG04, FPSG05, FPSG06, FPSG07) Polysomnograph (Model: FPSG08, FPSG09, FPSG10, FPSG11, FPSG12, FPSG13, FPSG14, FPSG15, FPSG16, FPSG17, FPSG18, FPSG19) Audiometer (TESTER, AUDITORY IMPEDANCE) Audiometer (Model: AX300 Pro, AX300 Max, AX400, AX400 Plus, AX400 Pro, AX400 Max, AX500, AX500 Plus, AX500 Pro) Audiometer (Model: AX800, AX800 Plus, AX800 Pro, AX800 Max, AX900, AX900 Plus, AX900 Pro, AX900 Max) Audiometer (Model: AX500 Max, AX600, AX600 Plus, AX600 Pro, AX600 Max, AX700, AX700 Plus, AX700 Pro, AX700 Max) Hearing Screen (Model: OS100, OS110, OS120, OS200, OS210, OS220, OS300, OS310, OS320) Audiometer (Model: AX100, AX100 Plus, AX100 Pro, AX100 Max, AX200, AX200 Plus, AX200 Pro, AX200 Max, AX300, AX300 Plus) Electronic Dryer (Model:FED78, FED79, FED80, FED81, FED82, FED83, FED84, FED85, FED86, FED87, FED88, FED89, FED90) 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) Electronic Dryer (Model:FED13, FED14, FED15, FED16, FED17, FED18, FED19, FED20, FED21, FED22, FED23, FED24, FED25) Electronic Dryer (Model:FED65, FED66, FED67, FED68, FED69, FED70, FED71, FED72, FED73, FED74, FED75, FED76, FED77) Electronic Dryer (Model:T86, T87, T88, T89, T90, T91, T92, T93, T94, T95, T96, T97, T98, T99, FED10, FED11, FED12) Electronic Dryer (Model:T48, T49, T50, T51, T52, T53, T54, T55, T56, T57, T58, T59, T60, T61, T62, T63, T64, T65, T66) Electronic Dryer (Model:FED91, FED92, FED93, FED94, FED95, FED96, FED97, FED98, FED99) 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:T29, T30, T31, T32, T33, T34, T35, T36, T37, T38, T39, T40, T41, T42, T43, T44, T45, T46, T47) Electronic Dryer (Model:FED26, FED27, FED28, FED29, FED30, FED31, FED32, FED33, FED34, FED35, FED36, FED37, FED38) Electronic Dryer (Model:FED39, FED40, FED41, FED42, FED43, FED44, FED45, FED46, FED47, FED48, FED49, FED50, FED51)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMI	Monitor, Bed Patient	General Hospital	Class 1	880.2400	2026-01-11
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2025-12-25
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2026-01-11

Official Correspondent

Yongfu Hu

US Agent Details

Creekon Yang Business: SPICA MEDTECH CORP Email: fda.agent@spicagloble.com Phone: (720) 6176666

Related Public Records

Same Entity

Fastsound Acoustic Technology (Hangzhou) Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27
K923074	Life-Tech Intl., Inc.	DANPLEX SCREENING AUDIOMETER	1992-09-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043139378. Last updated year: 2026. Please use registration number 3043139378 when referencing this establishment in official correspondence.