ZPower Rechargeable System for Hearing Aids

ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery Door Modules (00850034007328), 2 Silver-Zinc Batteries, and 1 AC Adapter, marked for…

Registry build 21.09.26

ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery Door Modules (00850034007328), 2 Silver-Zinc Batteries, and 1 AC Adapter, marked for demonstration use

29manufacturers in China registered for this device type
30catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (17), Fujian (6), Jiangsu (3). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OSM
Manufacturer City Province Registered as Device types
GN Resound China, Ltd. Xiamen Fujian Contract manufacturer 7
Xiamen Newsound Technology Co., Ltd. Xiamen Fujian Contract manufacturer 7
Huizhou Jinghao Medical Technology Co., Ltd. Huizhou Guangdong Contract manufacturer 5
Austar Hearing Science & Technology (Xiamen) Co., Ltd. Xiamen Fujian Contract manufacturer 5
VTech Communications Ltd Dongguan Guangdong Contract manufacturer 5
Xiamen Retone Hearing Technology Co., Ltd. Xiamen Fujian Contract manufacturer 5
Hangzhou Acosound Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 4
Minami Medical Technology (Guangdong) Co., Ltd. Zhongshan Guangdong Contract manufacturer 4
Sonova Hearing (Suzhou) Co., Ltd. Suzhou Jiangsu Contract manufacturer 3
Shenzhen Yuezhongxing Technology Co., Ltd. Huizhou Guangdong Repacker / relabeller 10
Hong YU Kang Technology (Guangdong) Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Kangfu Medical Equipment Factory Wenzhou Zhejiang Manufacturer 6

Showing 12 of 29. All 29 manufacturers in China registered for Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Record

Regulatory record for ZPower Rechargeable System for Hearing Aids
Listed by Zpower, LLC
FDA product code OSM
Device type Hearing Aid, Air-Conduction With Wireless Technology, Prescription
Device class Class 2
Regulation 21 CFR 874.3305
Premarket notification Exempt
Record published 2017-12-22
Record revised 2026-03-19 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Label carries lot or batch number
Storage Storage environment temperature 14 to 122 °F; Handling environment temperature 50 to 104 °F; Handling environment humidity 20 to 75 % RH; Handling environment atmospheric pressure from 11 KiloPascal
Packaging Alt cat no 9-06-0010, cat no 9-06-00109-ch, alt 9-06-00109-03s, cat no 9-06-00106-01, cat no 9-06-00106-ch

Catalogue Numbers

Catalogue numbers for ZPower Rechargeable System for Hearing Aids
Catalogue number Size Status
Z701-312 Cell Size 312 In distribution
Z501-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z101-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z602-312 Cell Size 312 In distribution
Z304-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z602-312 Cell Size 312 In distribution
Z602-312 Cell Size 312 In distribution
Z502-312 Cell Size 312 In distribution
Z602-312 Cell Size 312 In distribution
Z601-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z304-312 Cell Size 312 In distribution
Z601-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z101-312 Cell Size 312 In distribution
Z102-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z102-312 Cell Size 312 In distribution
Z202-312 Cell Size 312 In distribution
Z602-312 Cell Size 312 In distribution
Z304-312 Cell Size 312 In distribution
Z701-312 Cell Size 312 In distribution
Z502-312 Cell Size 312 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Widex Widex A/S 6,599
GN ReSound GN Hearing A/S 5,200
Oticon Oticon A/S 3,931
GN Hearing GN Hearing A/S 3,076
Signia WS Audiology USA, Inc. 2,980
Rexton WS Audiology USA, Inc. 2,876
Phonak Phonak, Inc. 2,406
Beltone GN Hearing A/S 2,196
Unitron Unitron Hearing Division 1,901
Unitron Unitron Hearing 1,745
HHM Oticon A/S 1,329
Miracle-Ear WS Audiology USA, Inc. 1,211

Showing 12 of 619. All products under Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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