FDA product code QKD: Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use
QKD is the FDA product code for massager, therapeutic, to internally massage trigger points in the pelvic floor musculature, prescription use. It is a Class II device, regulated under 21 CFR 890.5670 and reviewed by the Physical Medicine panel. Devices under QKD reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
A prescription device to massage irritable, sore trigger points in the pelvic floor musculature 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, Prescription Use |
| Device class | Class II |
| Regulation | 21 CFR 890.5670 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for QKD devices
openFDA lists no recalls for product code QKD.
Frequently asked questions
What is FDA product code QKD?
QKD is the FDA product code for massager, therapeutic, to internally massage trigger points in the pelvic floor musculature, prescription use. It is a Class II device, regulated under 21 CFR 890.5670 and reviewed by the Physical Medicine panel.
What device class is QKD?
Class II, regulation 21 CFR 890.5670. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QKD
- Run a recall and safety report across every QKD manufacturer
- Watch product code QKD 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.
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