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Electone, Inc.

United StatesFDA applicant, unverified

Devices
73

What Electone, Inc. makes

Electone, Inc. manufactures a range of hearing aids, including rechargeable and in-the-ear models such as the Z33, EAGLE I, AM 31, and M30. The company also produces personal amplifier devices, including the PREMIER CD RECHARGEABLE, PERSONAL AMPLIFIER MODULE, and ULTRA HELIX. Additional offerings include the AM 260 K-AMP, PREMIER CLASS D-ASP, and the SONATA U-01, along with programming modules like the MODULE PROGRAM.

Electone’s devices are classified under FDA categories Class I and Class II, with several listed via the 510(k) pathway. The company is based in the United States, and its products are registered under U.S. regulatory frameworks.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue73

Newest first, rows 1-50 of 73

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  • Z33 Ref K953050

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Premier Cd Rechargeable Ref K914797

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Eagle I Hearing Aid Ref K811988

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Premier Class D-Asp Ref K914798

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Am 260 K-Amp Ref K953052

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Am 31, Hearing Aid Ref K860008

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sonata U-01 Ref K955702

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Module Program Ref K942722

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Personal Amplifier Module Ref K830790

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Premier Asp/Cd Rechargeable Ref K914796

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Personal Amplifier Model Ultra Helix Ref K893433

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • M30 In The Ear Hearing Aid Ref K922501

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Bte Model Am 240 Ppl Ref K910102

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silver Rechargeable Module, Ite Ref K933045

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silver L Module, Ite Ref K933046

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silver Ppp Module, Ite Ref K933043

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold K Amp, Ite Ref K933037

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 770-Atc Ref K941133

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silver Compression Module, Ite Ref K933042

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Bte Model AM900 Pp Ref K910096

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Hearing Aid M35/M36 Series Ref K872556

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silver Ld Module, Ite Ref K933044

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Bte Model Am 130 D Ref K910100

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Stock Canal, In-The-Ear Hearing Aid Ref K911709

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Z35 Ref K953051

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Z24 Ref K953049

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • M32 In The Ear Hearing Aid Ref K922502

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pa Presidential Ii - Hearing Aid Ref K860191

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold Cd Ultra Mini Canal - Module Ref K951642

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Personal Amplifier Ref K832168

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold Af Module, Ite Ref K933038

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Bte Model Am 130 Pp Ref K910101

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold Cd Ultra Mini Canal Ref K950460

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • 800 Blue Ref K830303

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Premier K-Amp Ref K914799

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Ite Model Premier Ref K910097

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Am 300 Xp Ref K914947

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold Cd Module, Ite Ref K933040

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold K Amp Ultra Mini Canal Ref K950459

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cold Cd Asp Module, Ite Ref K933041

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • A & M 150 Pp (Hearing Aid) Ref K860244

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Bte Model Am 240 Hf Ref K910099

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Model 800, Behind-The-Ear Hearing Aid Ref K911706

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gold L Module, Ite Ref K933039

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Personal Amplifier Communicator Premium Ref K853606

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Electone Bte Model Am 130 Hf Ref K910103

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Personal Amplifier Silencer Ref K843980

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Pa Equalizer Ref K863787

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Model E-50, In-The-Ear Hearing Aid Ref K911708

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Silver Ultra Mini Canal Ref K950458

    Active Regimes: 510(k) Registry: 510(k) Class:I

Rows 1-50 of 73

Showing 1-50 of 73

Frequently asked questions

How many devices does Electone, Inc. have in the registry?

The registry currently lists 73 devices for Electone, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Electone, Inc.'s devices?

Among its 50 most recently registered devices, Electone, Inc. has devices listed in FDA 510(k) (50 devices).

What risk classes do Electone, Inc.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Electone, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Electone, Inc. in the registry?

The most recently registered devices listed for Electone, Inc. include Z33, PREMIER CD RECHARGEABLE, EAGLE I HEARING AID and PREMIER CLASS D-ASP.

Generated automatically from registry data and not verified by a human reviewer.