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) (10) Hearing Aid, Air Conduction With Wireless Technology (OSM) (10)

Premarket Exempt

Yes

Clear

ZPower Rechargeable System for Hearing Aids - 00811204030096 Catalog Number : 9-06-00142-05

Device Description : Contains Charger (00811204030157) and two battery assemblies for ZPower Recharge Contains Charger (00811204030157) and two battery assemblies 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 - 00811204030119 Catalog Number : 9-06-00142-07

Device Description : Contains Charger (00811204030164) and two battery assemblies for ZPower Recharge Contains Charger (00811204030164) and two battery assemblies for ZPower Rechargeable System for Hearing Aids, packaged without branding

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 - 00811204030126 Catalog Number : 9-06-00158-01

Device Description : Contains Charger (00811204030171) and two battery assemblies for ZPower Recharge Contains Charger (00811204030171) and two battery assemblies for ZPower Rechargeable System for Hearing Aids, packaged without branding

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 - 00811204030140 Catalog Number : 9-06-00143-05

Device Description : Contains Charger (00811204030195) and two battery assemblies for ZPower Recharge Contains Charger (00811204030195) and two battery assemblies for ZPower Rechargeable System for Hearing Aids, packaged without branding

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 - 00811204030157 Catalog Number : 9-05-00305-8

Device Description : Charger for ZPower Rechargeable System for Hearing Aids

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 - 00811204030164 Catalog Number : 9-05-00337-1

Device Description : Charger 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 - 00811204030171 Catalog Number : 9-05-00340-0

Device Description : Charger 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 - 00811204030188 Catalog Number : 9-05-00341-2

Device Description : Charger for ZPower Rechargeable System for Hearing Aids

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 - 00811204030195 Catalog Number : 9-05-00338-3

Device Description : Charger for ZPower Rechargeable System for Hearing Aids

Device Class :

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : OSM, ESD

Prescription Use : No

Device Count : 1

ZPower Rechargeable System for Hearing Aids - 00811204030201 Catalog Number : 9-06-00109-02

Device Description : Contains Charger (00811204030188) and two battery assemblies for ZPower Recharge Contains Charger (00811204030188) and two battery assemblies for ZPower Rechargeable System for Hearing Aids

Device Class : 1

Duns Number: 061455809

Premarket Exempt : Yes

Product Code : OSM, ESD

Prescription Use : No

Device Count : 1

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