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Index/Topics/FDA Regulations

FDA Regulations

Regulations set by the FDA for medical devices, including penis pumps.

Fact-Checks

3 results
Jan 13, 2026
Most Viewed

What are the documented risks and reported injuries from non‑FDA‑cleared penis pumps sold online?

Non‑FDA‑cleared penis pumps sold online are routinely marketed without required regulatory approval and safety features, and medical and regulatory sources document a pattern of injuries ranging from ...

Jan 21, 2026

Are there specific features or certifications to look for when buying a safe penis pump?

A buyer seeking a should prioritize specific safety features——plus proper fit, body‑safe materials, and preferably an ‑regulated, medical‑grade device when treating . Marketing claims about permanent ...

Jan 6, 2026

What do regulatory agencies and third-party lab tests reveal about Burn Peak's purity and label accuracy?

Publicly available reporting shows Burn Peak and its promoters repeatedly claim third‑party batch testing, manufacture in FDA‑registered/GMP‑certified facilities, and transparent ingredient disclosure...

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