FDA product code OSD: Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature
OSD is the FDA product code for massager, therapeutic, to internally massage trigger points in the pelvic floor musculature. It is a Class II device, regulated under 21 CFR 890.5670 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under OSD, 1 in the last five years. The average 510(k) review took 529 days (median 529); 529 days on average over the last three years. 1 De Novo request was granted under it.
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
Classification
| Field | Value |
|---|---|
| Device name | Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature |
| Device class | Class II |
| Regulation | 21 CFR 890.5670 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for OSD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 529 |
Compare with all 510(k) review times · Search every OSD clearance
Top OSD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Plus EV Holdings, Inc. D/B/A Intimate Rose | 1 | 2026-07-27 |
Most recent OSD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250419 | Plus EV Holdings, Inc. D/B/A Intimate Rose | Intimate Rose Pelvic Wand (Purple); Intimate Rose Bendable Pelvic Wand (Orange); Intimate Rose Temperature Pelvic Wand (Yellow) | 2026-07-27 | 529 |
Recalls for OSD devices
openFDA lists no recalls for product code OSD.
Frequently asked questions
What is FDA product code OSD?
OSD is the FDA product code for massager, therapeutic, to internally massage trigger points in the pelvic floor musculature. It is a Class II device, regulated under 21 CFR 890.5670 and reviewed by the Physical Medicine panel.
What device class is OSD?
Class II, regulation 21 CFR 890.5670. Typical premarket route: 510(k).
How long does a 510(k) take for product code OSD?
Across 1 cleared submissions the average was 529 days from receipt to decision (median 529).
Which companies have the most OSD clearances?
Plus EV Holdings, Inc. D/B/A Intimate Rose (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OSD
- Run a recall and safety report across every OSD manufacturer
- Watch product code OSD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Physical Medicine product codes · FDA product code lookup · 510(k) database search · 510(k) review times