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Ergoactives, LLC

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000015292 FEI 3007084179

Devices
11
Registrations
EUDAMEDFDA
FDA recalls
1

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA FEI, FDA recalls

What Ergoactives, LLC makes

Ergoactives, LLC manufactures mobility aids designed for stability and support, including walkers such as the X-TREME TERRAIN, 7G, and XG BLACK MAMBA, as well as lightweight models like the ULTRALITE and LIGHTBAUM. The portfolio also includes adjustable walkers (e.g., DUAL) and specialized versions for enhanced performance (e.g., HIGH PERFORMANCE). Some models feature reinforced frames (e.g., 2G, 2G BLACK PYTHON) for added durability.

These devices are classified as Class I under EU regulations and are listed in the eudamed registry. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue11

Newest first, rows 1-11 of 11

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  • Xg

    Class I
    Active CE MDR EUDAMED I

  • X-Treme Terrain

    Class I
    Active CE MDR EUDAMED I

  • 7g Ref A001

    Class I
    Active CE MDR EUDAMED I

  • Xg Black Mamba

    Class I
    Active CE MDR EUDAMED I

  • 2g Ref A048

    Class I
    Active CE MDR EUDAMED I

  • Ultralite

    Class I
    Active CE MDR EUDAMED I

  • 7g Black Mamba

    Class I
    Active CE MDR EUDAMED I

  • Dual

    Class I
    Active CE MDR EUDAMED I

  • High Performance

    Class I
    Active CE MDR EUDAMED I

  • 2g Black Python

    Class I
    Active CE MDR EUDAMED I

  • Lightbaum

    Class I
    Active CE MDR EUDAMED I

Rows 1-11 of 11

Company details

EUDAMED SRN
US-MF-000015292
FDA FEI number
3007084179
EUDAMED status
Active
EUDAMED registered name
ERGOACTIVES, LLC
Registered address
20725, NE 16TH AVE, 33179, MIAMI, United States
PRRC contact
MICHAEL LEWANDOWSKI(public in EUDAMED)

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 1 recall initiated by ERGOACTIVES, LLC, initiated on 2016-01-19. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2016

    • 19 Jan 2016 Z-2137-2016 Class II Terminated Products are marketed without a cleared 510k. Distribution: Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM,…
      Full distribution text Worldwide Distribution -- US, including the states of AL, AR, CA, FL, GA, KS, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, and WA; and, the countries of Ecuador & Venezuela.

From the company website

Read 18 Oct 2026

Ergoactives mobility products for seniors, adults & children provide comfort & stability for those dealing with an injury or disability. Browse our selection today!

From the manufacturer's own website. Source

Frequently asked questions

How many devices does ERGOACTIVES, LLC have in the registry?

The registry currently lists 11 devices for ERGOACTIVES, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list ERGOACTIVES, LLC's devices?

Among its 11 most recently registered devices, ERGOACTIVES, LLC has devices listed in EUDAMED (11 devices).

What risk classes do ERGOACTIVES, LLC's devices fall under?

Among its 11 most recently registered devices, the classes recorded for ERGOACTIVES, LLC's devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for ERGOACTIVES, LLC?

FDA recall records list 1 recall initiated by ERGOACTIVES, LLC, the most recent initiated on 2016-01-19. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from ERGOACTIVES, LLC in the registry?

The most recently registered devices listed for ERGOACTIVES, LLC include XG, X-TREME TERRAIN, 7G and XG BLACK MAMBA.

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