Skip to content

Access Point Medical, LLC

United StatesFDA applicant, unverified

Devices
4
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Access Point Medical, LLC makes

Access Point Medical, LLC manufactures mobility aids including manual wheelchairs such as the RUNABOUT and AXS-1 LITE, as well as transport chairs for patient movement. The company also produces respiratory therapy devices, including the DELUXE NEBULIZER for nebulized medication delivery.

These products are regulated under FDA Class I and Class II classifications, with relevant devices authorised via the 510(k) pathway. The company is based in the United States.

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

Catalogue4

Newest first, rows 1-4 of 4

  • Runabout Wheelchair Ref K050280

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

  • Transport Series Transport Chair Ref K050281

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

  • Deluxe Nebulizer Ref K063449

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

  • Axs-1 Lite Wheelchair Ref K050279

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

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Access Point Medical, LLC, the earliest on 2006-03-10 and the most recent on 2006-06-20. By recorded status: 6 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. 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.

  • 2006

    • 20 Jun 2006 Z-0154-2007 Unclassified (pre-2012) Terminated The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes. Distribution: Nationwide
    • 20 Jun 2006 Z-0155-2007 Unclassified (pre-2012) Terminated The fork component on the wheel of the Rollator can break due to the use of incorrect manufacturing material and/or molding processes. Distribution: Nationwide
    • 10 Mar 2006 Z-0202-2007 Unclassified (pre-2012) Terminated The canes were made of unacceptable materials and could break Distribution: Nationwide.
    • 10 Mar 2006 Z-0203-2007 Unclassified (pre-2012) Terminated The canes were made of unacceptable materials and could break Distribution: Nationwide.
    • 10 Mar 2006 Z-0204-2007 Unclassified (pre-2012) Terminated The canes were made of unacceptable materials and could break Distribution: Nationwide.
    • 10 Mar 2006 Z-0205-2007 Unclassified (pre-2012) Terminated The canes were made of unacceptable materials and could break Distribution: Nationwide.

Frequently asked questions

How many devices does Access Point Medical, LLC have in the registry?

The registry currently lists 4 devices for Access Point Medical, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Access Point Medical, LLC's devices?

Among its 4 most recently registered devices, Access Point Medical, LLC has devices listed in FDA 510(k) (4 devices).

What risk classes do Access Point Medical, LLC's devices fall under?

Among its 4 most recently registered devices, the classes recorded for Access Point Medical, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Access Point Medical, LLC?

FDA recall records list 6 recalls initiated by Access Point Medical, LLC, the most recent initiated on 20 Jun 2006. 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 Access Point Medical, LLC in the registry?

The most recently registered devices listed for Access Point Medical, LLC include RUNABOUT WHEELCHAIR, TRANSPORT SERIES TRANSPORT CHAIR, DELUXE NEBULIZER and AXS-1 LITE WHEELCHAIR.

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