510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSDClass II

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

21 CFR 890.5670 / Physical Medicine
FDA source (opens on fda.gov)

OSD is the FDA product code for Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, a class II device type, regulated under 21 CFR 890.5670. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OSD
Device name
Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
FDA 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
Regulation
21 CFR 890.5670
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code OSD

By decision year
2 clearances under product code OSD with a decision year between 2012 and 2026, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OSD by decision year
YearClearances
20121
20261

Applicants with the most clearances

Product code OSD
Applicants holding the most 510(k) clearances under product code OSD
ApplicantClearances
National Center for Pelvic Pain Research Devices1
Plus EV Holdings, Inc. D/B/A Intimate Rose1

Companies listing this code with FDA

Companies whose registered establishments list this code