Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature

OSD · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.5670

Classification

FDA Product Code: OSD
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 890.5670
Review panel: PM
Medical specialty: Physical Medicine
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Rectal or vaginal use manual therapeutic massager device to massage irritable, sore trigger points (trps) in the pelvic floor musculature in order to reduce internal pelvic floor trigger point sensitivity

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown