Mr. Alan C. Heller
President/CEO
Wello Inc.
15960 Midway Road
Addison , TX 75001-4280
United StatesFEI 3011214569Issued Nov 8, 2023Center for Devices and Radiological Health
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011214569.
Violations3
Issue DateNov 8, 2023
Product TypeMedical Devices
StatusClosed
Closeout LetterOct 28, 2024
Letter Details
Firm
Wello Inc.
Location
Mr. Alan C. Heller
President/CEO
Wello Inc.
15960 Midway Road
Addison , TX 75001-4280
United States
FEI Number
3011214569
Country
United States
Issue Date
November 08, 2023
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Closed
Closeout Letter
October 28, 2024
Summary
Wello Inc. was warned for manufacturing the welloStationX medical device with misbranded labeling in violation of FDA regulations. The company failed to include a required unique device identifier (UDI) on device labels in both plain-text and machine-readable formats as mandated by 21 CFR 801.20(a) and related regulations, making the critical identification information not prominently displayed or easily readable to consumers. The violations were identified during an FDA inspection conducted at the company's Addison, Texas facility in June 2023.
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