Data / Medical devices / United States / WillowWood Global LLC
WillowWood Global LLC: FDA-registered device maker in Mt Sterling, OH, United States, 1 510(k) clearance
WillowWood Global LLC is registered with the FDA (registration 1522166) in Mt Sterling, OH, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 11, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1522166
- Address
- 15441 Scioto Darby RD., Mt Sterling, OH, United States, 43143
- Owner or operator
- WillowWood Global LLC (1522166)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 23, 1992
- Registered through
- 2027
- Brand names listed
- Alignment component, multiple, Alpha Basic Liner, Alpha Classic Liner, Alpha Control Liner, Alpha Design Liner, Alpha Duo Liner, Alpha Hybrid Liner, Alpha Liner and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Component, External, Limb, Ankle/Foot | ISH | 1 | Manufacturer | accessdata.fda.gov |
| Cover, Limb | IPM | 1 | Manufacturer | accessdata.fda.gov |
| Device, Prosthesis Alignment | IQO | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Joint, Knee, External Limb Component | ISY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Prosthesis, Thigh Socket, External Component | ISS | 1 | Manufacturer | accessdata.fda.gov |
| Valve, Prosthesis | ISP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 11, 2023 | K223738 | Alpha Control Liner System (ACLS) | GXY | Substantially Equivalent | Coapt | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 20, 2021 | 87825 | Class II | Ongoing | Alpha Interlock Suspension System Lanyard Body: An external prosthetic device. The Alpha Lanyard includes suction with a one-way air expulsion valve plus a locking mechanism. Product design features an easy release mecha | the firm discovered that, starting on April 1, 2020, a 3/8 dowel pin was used in place of the 5/8 pin. Over time, the shorter pin may not engage in either the upper or lower body, causing the cord to come loose or slip which could result in the loss of suspension. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Thigh Socket, External Component
- All makers of Valve, Prosthesis
- All makers of Device, Prosthesis Alignment
- All makers of Joint, Knee, External Limb Component
- All makers of Component, External, Limb, Ankle/Foot
- All makers of Electrode, Cutaneous
Updated January 11, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.