ZPOWER, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Hearing Aid, Air Conduction (ESD) (6) Hearing Aid, Air Conduction With Wireless Technology (OSM) (6)

Premarket Exempt

Yes

Clear

ZPower Rechargeable System for Hearing Aids - 00850034007755 Catalog Number : 9-05-00267-04

Device Description : Battery Door Module for ZPower Rechargeable System for Hearing Aids

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : ESD, OSM

Prescription Use : No

Device Count : 1

ZPower Rechargeable System for Hearing Aids - 00850034007762 Catalog Number : 9-06-00143-03-NA

Device Description : ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (0085003400 ZPower Rechargeable System for Hearing Aids Kit. Includes 1 Charger (00850034007359), 2 Battery Door Modules (00811204030225), 2 Silver-Zinc Batteries, and 1 AC Adapter

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : ESD, OSM

Prescription Use : No

Device Count : 1

ZPower Rechargeable System for Hearing Aids - 80850034007003 Catalog Number : 9-06-00048-1

Device Description : Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged In Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : ESD, OSM

Prescription Use : No

Device Count : 1

ZPower Rechargeable System for Hearing Aids - 80850034007072 Catalog Number : 9-06-00071-6

Device Description : Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged In Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : OSM, ESD

Prescription Use : No

Device Count : 1

ZPower Rechargeable System for Hearing Aids - 80850034007157 Catalog Number : 9-06-00073-0

Device Description : Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged In Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : ESD, OSM

Prescription Use : No

Device Count : 1

ZPower Rechargeable System for Hearing Aids - 80850034007195 Catalog Number : 9-06-00074-2

Device Description : Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged In Battery Door Module for ZPower Rechargeable System for Hearing Aids (Packaged Individually)

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : OSM, ESD

Prescription Use : No

Device Count : 1

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