GenderBender LLC
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
Our records indicate that you have not registered or listed these devices for fiscal year 2026.
FDA published a close-out letter on Apr 2, 2026. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The firm failed to register and list its breast binder devices with FDA.
Supporting FDA text
Source excerpt · automated text-match checkOur records indicate that you have not registered or listed these devices for fiscal year 2026.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Our records indicate that you have not registered or listed these devices for fiscal year 2026.
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Register establishment and list devices with FDA
- Provide written response within fifteen business days detailing corrections
- Explain how firm plans to prevent future violations
- Include documentation of corrections and corrective actions
- Provide timetable for implementation if corrections take time
- State reason for delay if corrections cannot be completed in fifteen days