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Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K252552

by Shenzhen Changkun Technology Co., Ltd.

Identifiers

510(k) Number
K252552 FDA 510(k)
FDA Product Code
KPI FDA 510(k)
Models / Variants
PD2301 FDA 510(k)EUDAMED
PD2302 FDA 510(k)EUDAMED
PD2303 FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5320 FDA 510(k)
Regulation Number
876.5320 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an Electrical, Non-Implantable Stimulator for Incontinence, designed to provide pelvic floor rehabilitation therapy. It delivers controlled electrical stimulation to improve muscle function and manage urinary or fecal incontinence through targeted nerve and muscle activation.

The device is supplied as a reusable medical instrument, intended for use in clinical settings such as urology and gastroenterology. It operates under FDA 510(k) clearance and European MDD compliance, with no specified sterility requirements or MRI safety constraints. Models PD2301, PD2302, and PD2303 are referenced in regulatory filings, though no additional size or configuration details are provided in the data.

Frequently asked questions

What clinical specialties is this pelvic floor rehabilitation device primarily intended for, and how does it function in those settings?

This device is designed for use in urology and gastroenterology clinical settings, as indicated by its regulatory filings. It functions as an electrical, non-implantable stimulator for incontinence, delivering controlled electrical stimulation to improve pelvic floor muscle function. This helps manage urinary or fecal incontinence by activating targeted nerves and muscles, making it relevant for patients with incontinence-related conditions in these specialties.

Is this device single-use or reusable, and what are the implications for clinical workflows?

The device is reusable, as explicitly stated in the description. This means it is intended for use in clinical settings where multiple patients may benefit from the therapy, reducing waste and cost compared to single-use alternatives. However, since no sterility requirements are specified, clinical staff must follow proper cleaning and disinfection protocols to ensure safe reuse across patients.

Are there different models available, and if so, how might they differ in terms of use or configuration?

Three models are referenced in regulatory filings: PD2301, PD2302, and PD2303. While the data does not provide specific technical differences (such as electrode configurations, stimulation intensities, or additional features), the existence of multiple models suggests potential variations in functionality or patient-specific applications. Clinicians should consult manufacturer documentation or support for model-specific guidance tailored to their patient needs.

What regulatory pathways has this device followed, and how does that affect its availability or use?

The device has undergone FDA 510(k) clearance and complies with the European Medical Device Directive (MDD), confirming its regulatory approval in both markets. This means it is legally available for clinical use in the U.S. and EU, though specific country requirements (e.g., local distribution or labeling adjustments) may apply. The clearance also indicates it is considered substantially equivalent to a predicate device, ensuring its safety and effectiveness have been evaluated against established standards.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shenzhen Changkun Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K252552 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 21, 2026