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Equilibrated Bio Systems, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
7

What Equilibrated Bio Systems, Inc. makes

Equilibrated Bio Systems, Inc. manufactures exercise testing equipment, including the MONARK 869 ERGOMETER for cardiovascular assessments, and infant positioning devices like the EBS2605 INFANT HUGGER. The company also produces environmental air controllers such as the TURBOAIRE CHALLANGER, tonometry devices like the EBS 775 TONOMETER, and spinal support frames including the ADULT ZEE-FRAME and ZEE-FRAME. Additional offerings include the SPIROCAL, a device for respiratory or pulmonary testing.

The company’s products are regulated under FDA 510(k) clearance, with devices classified as Class I and Class II. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.

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

Catalogue7

Newest first, rows 1-7 of 7

  • Monark 869 Ergometer Ref K855102

    Class II
    Active 510(k) 510(k) II
  • EBS2605 Infant Hugger Ref K892705

    Class II
    Active 510(k) 510(k) II
  • Turboaire Challanger Environmental Air Controller Ref K843996

    Class II
    Active 510(k) 510(k) II
  • Adult Zee-Frame Ref K790410

    Class I
    Active 510(k) 510(k) I
  • Zee-Frame Ref K781509

    Class I
    Active 510(k) 510(k) I
  • Ebs 775 Tonometer Ref K781386

    Class I
    Active 510(k) 510(k) I
  • Spirocal Ref K791294

    Class I
    Active 510(k) 510(k) I

Frequently asked questions

How many devices does Equilibrated Bio Systems, Inc. have in the registry?

The registry currently lists 7 devices for Equilibrated Bio Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Equilibrated Bio Systems, Inc.'s devices?

Among its 7 most recently registered devices, Equilibrated Bio Systems, Inc. has devices listed in FDA 510(k) (7 devices).

What risk classes do Equilibrated Bio Systems, Inc.'s devices fall under?

Among its 7 most recently registered devices, the classes recorded for Equilibrated Bio Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Equilibrated Bio Systems, Inc. in the registry?

The most recently registered devices listed for Equilibrated Bio Systems, Inc. include MONARK 869 ERGOMETER, EBS2605 INFANT HUGGER, TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER and ADULT ZEE-FRAME.

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