Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
QKD · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5670
Classification
FDA Product Code
QKD
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 890.5670
Review panel
PM
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A prescription device to massage irritable, sore trigger points in the pelvic floor musculature to reduce internal pelvic floor trigger point sensitivity.