Product code OSD— Physical Medicine

AHIP INTERNAL TRIGGER POINT WAND MODEL: 1

Classification name: Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
Device class: Class 2
Regulation: 21 CFR 890.5670
Advisory panel: Physical Medicine
Total cleared: 1
First cleared: 2012-11-20
Most recent: 2012-11-20

FDA classification 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”
— U.S. Food and Drug Administration, device classification record for product code OSD under 21 CFR 890.5670, via openFDA

Market context for product code OSD

FDA has cleared 1 device under product code OSD, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OSD

National Center For Pelvic Pain Research Devices,1 clearance

Recent clearances under product code OSD

DEN100023 — AHIP INTERNAL TRIGGER POINT WAND MODEL: 1National Center For Pelvic Pain Research Devices,·2012-11-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.