FDA product code QTC: Adult Portable Bed Rails For Medical Purposes
QTC is the FDA product code for adult portable bed rails for medical purposes. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel. Devices under QTC reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for QTC devices, 2 initiated in the last five years.
Definition
An adult portable bed rail is a device intended for medical purposes to assist a patient to perform a specific function, including but not limited to assisting impaired individuals (e.g., disabled, injured, or those post-surgery or hospitalized) with transfer in and out of bed, and repositioning, to reduce risk of falling or fracture. This device may mitigate the risk of falling due to the effects of balance disorders or other medical conditions. This does not include guardrails or side rails intended for use on FDA regulated hospital beds and does not include portable bed rails used for pediatrics.
Classification
| Field | Value |
|---|---|
| Device name | Adult Portable Bed Rails For Medical Purposes |
| Device class | Class I |
| Regulation | 21 CFR 890.5050 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) exempt |
Recalls for QTC devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-03-05.
| Year | Recalls |
|---|---|
| 2024 | 2 |
Frequently asked questions
What is FDA product code QTC?
QTC is the FDA product code for adult portable bed rails for medical purposes. It is a Class I device, regulated under 21 CFR 890.5050 and reviewed by the Physical Medicine panel.
What device class is QTC?
Class I, regulation 21 CFR 890.5050. Typical premarket route: 510(k) exempt.
Have QTC devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2024-03-05.
Next steps
- Run an FDA pathway report with predicate devices for product code QTC
- Run a recall and safety report across every QTC manufacturer
- Watch product code QTC 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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