Identifiers
- 510(k) Number
- K130229 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Palm Bladder Scanner is a portable ultrasound device designed for non-invasive bladder volume assessment. It utilises ultrasound technology to measure residual urine volume in the bladder, aiding in clinical evaluations of urinary retention or post-micturition assessment.
This device is intended for single-use or reusable applications in clinical settings, including hospitals and medical offices. Supplied sterile or non-sterile as specified, it adheres to FDA 510(k) clearance under the Radiology advisory committee and MDD compliance. The device is classified under product code IYO and requires proper storage as per manufacturer guidelines.
Frequently asked questions
What clinical scenarios is the Palm Bladder Scanner primarily used for?
The Palm Bladder Scanner is designed for non-invasive bladder volume assessment, particularly to measure residual urine volume after urination. Clinicians use it to evaluate urinary retention or perform post-micturition assessments, helping diagnose or monitor conditions like bladder dysfunction or obstruction.
How is the Palm Bladder Scanner supplied, and can it be reused?
The Palm Bladder Scanner is available in both sterile and non-sterile versions, depending on the clinical setting and procedure requirements. It is explicitly labeled for single-use or reusable applications, meaning it can be used multiple times if properly cleaned, disinfected, and maintained according to manufacturer guidelines.
What storage instructions should I follow for this device?
The Palm Bladder Scanner requires proper storage as per manufacturer guidelines, though specific conditions (e.g., temperature, humidity) aren’t detailed in the data. Since it’s a portable ultrasound device, it should be kept in a clean, dry environment away from extreme temperatures or direct sunlight to preserve functionality and hygiene.
How do I know if this device meets regulatory standards for use in my country?
The Palm Bladder Scanner holds FDA 510(k) clearance under the Radiology advisory committee (K130229) and complies with the MDD (Medical Device Directive). For international use, you must verify local regulatory requirements, as compliance with these approvals does not automatically extend to other jurisdictions.
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. Sources consulted: Palm Equipment| Kajak & Paddeln | Gear for Paddlers
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K130229 | Class II | Active |
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Manufacturer
- Manufacturer
- Mianyang Meike Electronic Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K130229 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026