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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Flux Lab Pte. Ltd. d/b/a The Fluxion

Issued · Posted by FDA

FDA published a close-out letter on Apr 7, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Chest Binders: In contrast, chest binders are used primarily by transgender individuals and those with gender dysphoria to compress and flatten the chest.

Passage 2

Binding can be a significant step in affirming one’s gender and can help alleviate gender dysphoria.

Passage 3

Freedom from Chest Dysphoria: Those who seek a secure, snug fit without the discomfort of breast pressure to alleviate chest dysphoria and promote overall well-being

Passage 4

Our records indicate that you have not registered or listed these devices for fiscal year 2026.