Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong.
- Shenzhen Comfort Technology Co., Ltd. Guangdong
What Is This Device?
A prescription device to massage irritable, sore trigger points in the pelvic floor musculature to reduce internal pelvic floor trigger point sensitivity.
How Is QKD Classified?
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use is FDA product code QKD, Class 2, 21 CFR 890.5670.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
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