DeviceClearance

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
2
First cleared
Most recent

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 2 devices under product code OSD between 2012 and 2026, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code OSD

Recent clearances under product code OSD

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