Male Wellness Device Manufacturers | Traction Devices & Sleeves

QQIP Editorial · Updated 10 October 2026

The traction device and its pressure claim

RENCHU RC-BL001 is a powered device with three modes (massage, stimulation and traction) and four intensity levels, rated at or below 5 V and 500 mA. RENCHU claims up to 35 kPa negative pressure, about 10.3 inHg. For comparison, FDA guidance on external penile rigidity devices says vacuum pumps typically draw less than 17 inHg and recommends a manually operated quick release. Ask RENCHU whether RC-BL001 has a manual release and how the pressure was measured.

Claims decide whether it is a medical device

In the US, external penile rigidity devices intended to create or maintain an erection for men with erectile dysfunction are Class II under 21 CFR 876.5020. FDA’s guidance excludes devices marketed for penile enlargement or curvature correction from that classification, so those claims are regulated differently. Decide your claims first, then check the device’s regulatory status with RENCHU.

The sleeve set is not a condom

RENCHU’s three-variant silicone sleeve set (No. 1, No. 2, No. 3) varies in inner texture, thickness and softness, and RENCHU states it is not a condom substitute. Your packaging must not imply contraception or STI protection; in the EU, products intended for those uses are Class IIb medical devices. RENCHU does not publish dimensions, so request them.

Frequently asked questions

Is RC-BL001 water-resistant?

Not stated. Do not assume it; ask RENCHU.

Is RENCHU a medical-device company?

Its company name refers to medical supplies, but QQIP has not established the regulatory status of these products. Ask for registration documents.

Are minimums published?

No. Confirm with RENCHU.

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