FDA.reportPublic FDA data

ZPower Rechargeable System for Hearing Aids

Primary DI
00850034007571
Brand
ZPower Rechargeable System for Hearing Aids
Company
ZPOWER, LLC
Model
Z602-312
Catalog number
9-06-00106-02-NA
Device description
ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007441), 2 Battery Door Modules (00850034007656), 2 Silver-Zinc Batteries, and 1 AC Adapter
Published
2017-12-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air Conduction
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850034007571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850034007571008500340075718500340075710850034007571

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure11 KiloPascal0 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature14 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-364-2909support@zpowerbattery.com

Regulatory Flags#

DUNS number
061455809
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811204030539ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-022019-05-01
00811204030546ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-032019-05-01
00811204030553ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-042019-05-01
00811204030560ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-052019-05-01
00850034007434ZPower Rechargeable System for Hearing AidsZ602-3129-05-00267-012017-12-22
00850034007496ZPower Rechargeable System for Hearing AidsZ701-3129-05-00245-012017-12-22
00850034007656ZPower Rechargeable System for Hearing AidsZ602-3129-05-00267-022017-12-22
00850034007663ZPower Rechargeable System for Hearing AidsZ602-3129-05-00267-032017-12-22
00811204030591ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-01-NA2019-11-08
00811204030621ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-02-NA2019-11-08
00811204030652ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-03-NA2019-11-08
00811204030683ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-04-NA2019-11-08
00811204030713ZPower Rechargeable System for Hearing AidsZ701-3129-06-00162-05-NA2019-11-08
00811204030287ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-02-NA2019-05-01
00811204030331ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-03-NA2019-05-01
00811204030386ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-04-NA2019-05-01
00811204030430ZPower Rechargeable System for Hearing AidsZ701-3129-06-00109-05-NA2019-05-01
80850034007003ZPower Rechargeable System for Hearing AidsZ101-3129-06-00048-12017-12-31
80850034007072ZPower Rechargeable System for Hearing AidsZ202-3129-06-00071-62017-12-31
80850034007157ZPower Rechargeable System for Hearing AidsZ302-3129-06-00073-02017-12-31

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05714878800291MIRACLE EARWs Audiology Usa, Inc.OSM2026-07-29
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