Data / Medical devices / United States / Onekubeddesigns
Onekubeddesigns: FDA-registered device maker in Spicewood, TX, United States, 1 510(k) clearance
Onekubeddesigns is registered with the FDA (registration 3013025777) in Spicewood, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 9, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013025777
- Address
- 7501 E. State Highway 71 Building #8, Spicewood, TX, United States, 78669
- Owner or operator
- OneKubedDESIGNS (10052842)
- Roles
- Repackager or relabeler
- First device listed
- August 24, 2017
- Registered through
- 2027
- Brand names listed
- FOLD & GO Electric Wheelchairs®
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Powered | ITI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| August 9, 2017 | K170787 | Powered Wheelchair DYW30A(D09) | ITI | Substantially Equivalent | Nanjing Jin Bai HE Medical Apparatus Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 9, 2017. 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.