Tuning Fork Metal Alloy C128

A hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is…

Registry build 21.09.26

A hand-held, mechanical test instrument designed as an acoustic resonator used to test the hearing acuity of a patient, to diagnose hearing disorders, and to test for vibratory sense. It is usually made of stainless steel in the form of a two-pronged fork with the prongs (tines) formed from a U-shaped bar with a handle attached at the base of the “U”. It resonates at a specific constant pitch when set vibrating by striking it against a surface or with an object. The pitch that a particular tuning fork generates depends on the length of the two prongs. This is a reusable device.

11manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Zhejiang (5), Shanghai (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code GWX
Manufacturer City Province Registered as Device types
Guangzhou Goldsun Electronic Co., Ltd. Guangzhou Guangdong Contract manufacturer 6
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Saferlife Products Co., Ltd. Guangzhou Guangdong Contract manufacturer 58
Hangzhou Haizhu MIM Products Co., Ltd. Hangzhou Zhejiang Exporter 28
Wenzhou Kangju Medical Instrument Co., Ltd. Wenzhou Zhejiang Contract manufacturer 15
ADC Ningbo Co., Ltd. Ningbo Zhejiang Exporter 13
MDF Instruments Medifriend Inc. Song Jiang District Shanghai Repacker / relabeller 13
Ningbo Yongjin Medical Instruments Manufacture Co., Ltd. Ningbo Zhejiang Manufacturer 8
Ningbo Haishu Haoxin Medical Instrument Co., Ltd. Ningbo Zhejiang Manufacturer 6
Taihu Huamei Medical Equipment Co., Ltd. Anqing Anhui Contract manufacturer 5

Record

Regulatory record for Tuning Fork Metal Alloy C128
Listed by N S Surgical Company
FDA product code GWX
Device type Fork, Tuning
Device class Class 1
Regulation 21 CFR 882.1525
Premarket notification Exempt
Record published 2023-04-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization, Ultraviolet Light, Ethylene Oxide
Label carries lot or batch number, manufacturing date
Sizes Length 20 cm

Catalogue Numbers

Catalogue numbers for Tuning Fork Metal Alloy C128
Catalogue number Size Status
10-067-10 Length 20 cm In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Fentex Fentex medical GmbH 22
RZ Medizintechnik GmbH RZ Medizintechnik Gmbh 20
Aesculap Aesculap AG 15
ADC® American Diagnostic Corp. 13
HNM Medical HNM Stainless, LLC. 12
Integra® Miltex® Integra LifeSciences Production Corporation 11
BR Surgical, LLC BR Surgical LLC 11
Bear Bear-ENT, LLC 10
Ambler Surgical Ambler Surgical, LLC 7
Sontec Tuning Fork Sontec Instruments, Inc. 7
mytaMed Mytamed, Inc. 6
Integra® Jarit® Integra LifeSciences Production Corporation 5

Showing 12 of 34. All products under Fork, Tuning

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer