Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Per your firm’s website: “Chest binding should never be harmful — yet we still see people getting injured from unsafe or poorly designed binders. We engineered our design to offer moderate compression, enough to help with gender dysphoria without cutting off your airflow or bruising your torso.”
Passage 2Per your firm’s website: “Just about 5 years ago we were prepping to launch a Kickstarter campaign for our Bareskin Binder: a masculine swim top/binder option for folx who didn’t have the perfect dysphoria-easing solution”
Passage 3Per your firm’s website: “Chest binding is the act of compressing breast tissue to create a flatter chest appearance. Many transmasc, nonbinary, and gender-nonconforming people bind as part of their gender expression or to ease gender dysphoria.”
Passage 4Our records indicate that you have not registered or listed these devices for fiscal year 2026.