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Bloomex International, Inc.

United StatesFDA applicant, unverified

Devices
16

What Bloomex International, Inc. makes

Bloomex International, Inc. manufactures electronic muscle exercise equipment, including resistance-based devices like the BX-400 Jesse Jimbody, BX-1000 Isomatic, and BX-600 EMS, as well as professional and sports models such as the Model P-8 and BX-400 Sport. The company also produces solar-powered exercise systems like the Solar Tone and Slimertone, designed for muscle stimulation and toning.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Bloomex International, Inc. is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue16

Newest first, rows 1-16 of 16

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  • Slendertone Ref K790120

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

  • Bx-400 Jesse Jimbody Ref K813410

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

  • Electronic Muscle Exercise Equipment Ref K841779

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

  • Bx-400 Ref K842142

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

  • Model P-8 Professional Ref K811114

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

  • Bx-400 Sport Ref K813443

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

  • Electronic Muscle Exerciser Ref K821110

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

  • Bx-1000 Isomatic Ref K820080

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

  • Bx-400S Ref K942195

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

  • Bx-200 Sc Ref K943185

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

  • Solar Tone Ref K802304

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

  • Bx-600 Ems Ref K832976

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

  • Mbi-4 Ref K810247

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

  • Bx-500 Electronic Muscle Exerciser Ref K822287

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

  • Elite Ref K810246

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

  • Minitone Ref K810975

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

Rows 1-16 of 16

Frequently asked questions

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

The registry currently lists 16 devices for Bloomex International, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Bloomex International, Inc.'s devices?

Among its 16 most recently registered devices, Bloomex International, Inc. has devices listed in FDA 510(k) (16 devices).

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

Among its 16 most recently registered devices, the classes recorded for Bloomex International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Bloomex International, Inc. include SLENDERTONE, BX-400 JESSE JIMBODY, ELECTRONIC MUSCLE EXERCISE EQUIPMENT and BX-400.

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