ONEKUBEDDESIGNS

FDA Device Registration & Listing · Spicewood, TX, US · Registration 3013025777

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013025777
FEI Number
3013025777
Entity Name
ONEKUBEDDESIGNS
City/State/Country
Spicewood, TX, US
Establishment Address
7501 E. State Highway 71, Building #8, Spicewood, TX 78669, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
OneKubedDESIGNS (Owner Number: 10052842)
Owner / Operator Contact Address
2800 Indian Divide Road, Spicewood, TX 78669, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K170787
PMA Number
N/A

All Registered Proprietary Names

FOLD & GO Electric Wheelchairs®

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ITI Wheelchair, Powered Physical Medicine Class 2 890.3860 2017-08-24

Official Correspondent

Michele Klein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OneKubedDESIGNS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K853594 Vessa , Ltd. VESSA FLIVVA 1985-09-24
K142783 Heartway Medical Products Co., Ltd. HEARTWAY Electrically Powered Wheelchair P27 2015-06-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Z-0006-2018 Permobil, Ab Arvaltsvagen 10 2
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Z-0039-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors.
Z-0040-2007 Eagle Parts and Products 2
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013025777. Last updated year: 2026. Please use registration number 3013025777 when referencing this establishment in official correspondence.
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