Fingertip Pulse Oximeter
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K140582 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fingertip Pulse Oximeter JPD-500D OLED is a non-invasive medical device classified as a pulse oximeter, designed to measure oxygen saturation (SpO₂) and pulse rate in peripheral blood. It operates by transmitting light through a fingertip to detect hemoglobin oxygenation levels, providing real-time physiological monitoring for clinical and non-clinical use.
This device is supplied as a single-use or reusable (depending on manufacturer guidelines) portable unit with an OLED display for clear readouts. It is intended for use in healthcare settings, home monitoring, sports, and travel environments. The device adheres to FDA 510(k) clearance under the Traditional pathway and MDR compliance, with no specific MRI safety restrictions noted. Storage requires protection from extreme temperatures and physical damage.
Frequently asked questions
How is the Fingertip Pulse Oximeter JPD-500D OLED intended to be used in different environments like healthcare, home, or travel?
The device is designed for versatile use across healthcare settings, home monitoring, sports, and travel. It measures oxygen saturation (SpO₂) and pulse rate non-invasively by placing the fingertip on the sensor, making it practical for real-time monitoring in various environments where portable, easy-to-use physiological tracking is needed.
Is the Fingertip Pulse Oximeter JPD-500D OLED meant for single-use or can it be reused? How should it be handled?
The device can be used either as single-use or reusable, depending on the manufacturer’s guidelines. Since reuse isn’t inherently prohibited, proper cleaning and maintenance (if reused) are critical to ensure accuracy and hygiene, especially in clinical settings. Always follow the manufacturer’s instructions for handling to avoid contamination or damage.
What kind of display does the JPD-500D OLED use, and how does it affect usability?
The device features an OLED display, which provides clear and energy-efficient visual readouts of oxygen saturation (SpO₂) and pulse rate. This type of display enhances visibility in various lighting conditions, making it easier for users—whether clinicians, athletes, or travelers—to monitor their physiological data without glare or strain.
What storage conditions should be followed for the Fingertip Pulse Oximeter JPD-500D OLED to maintain its performance?
The device should be stored in a protected environment away from extreme temperatures and physical damage. Proper storage ensures the sensor and display remain functional, as heat, cold, or impacts could compromise accuracy or readability over time.
What regulatory pathways does the Fingertip Pulse Oximeter JPD-500D OLED follow, and how does that impact its use?
The device is cleared under the FDA’s 510(k) Traditional pathway and complies with MDR (Medical Device Regulation) standards. This means it has undergone evaluation for safety and effectiveness as a pulse oximeter, ensuring it meets regulatory requirements for clinical and non-clinical use. No specific MRI safety restrictions are noted, but always verify compatibility with local guidelines.
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: Fingertip Pulse Oximeter - Shenzhen Jumper Medical Equipment Co., Ltd., JPD-500D OLED Fingertip Pulse Oximeter - Supplier of Household Medical ..., Shenzhen Jumper Medical Equipment Co., Ltd., Shenzhen Jumper Medical Equipment Co., Ltd., Pulse Oximeter from China Manufacturers - Shenzhen Jumper Medical ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K140582 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Jumper Medical Equipment Co., Ltd.
Sources (2)
- FDA 510(k) K140582 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026