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510(k) Data Aggregation
K Number
K234110Device Name
Belun Ring BLR-200 (BLR-200)
Manufacturer
Belun Technology Company Limited
Date Cleared
2024-10-11
(289 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Belun Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Belun Ring BLR-200 is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for spot-checking and/or continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
Device Description
Belun Ring BLR-200 consists of two parts: a Ring, and a host program. The Ring, which has smooth and light design and is easy to wear and take off, is intended to be worn on the bottom of index finger providing comfortable and accurate measurements. To make the Optical module appropriately contact with the soft part of the finger, the Ring arm is designed to be changeable for fitting different sizes of fingers. The Ring transfers the collected data to host via Bluetooth low power technology. The host program translates the collected data into text and graph which can be easily interpreted by the user.
The system consists of two main platforms, namely Ring and host. It includes one embedded software and one host program, namely Ring firmware embedded in Ring and Belun Ring Management (BRM) executed in host respectively. The Ring is responsible for signal acquisition, data processing, parameters calculation (SpO2/PR algorithm), sensor interfacing and data storage. The host is for data display, data export and user interface. The system is modularized, and the communication protocol is proprietary. The system is secured with cybersecurity measures.
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K Number
K222579Device Name
Belun Sleep System BLS-100
Manufacturer
Belun Technology Company Limited
Date Cleared
2023-02-23
(182 days)
Product Code
MNR
Regulation Number
868.2375Why did this record match?
Applicant Name (Manufacturer) :
Belun Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
Device Description
The Belun Sleep System BLS-100 comprises a sensor that is worn on the proximal phalanx of index finger (Belun Ring) over-night whilst the subject is sleeping and a stand-alone analysis software (Belun Sleep AI). The Belun Ring has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is placed on the proximal phalanx of the index finger, with the sensor window applied against the palmar side of the proximal phalanx of the index finger. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement. The data recorded by the Belun Ring is stored in device on-board memory. The data is exported when the Belun Ring is returned to the prescribing HCP via USB or Bluetooth and passed to the Belun Sleep AI Software, which is standalone PC software. The Belun Sleep Al loads and processes the signal from the exported data and generates the apnea-hypopnea index (bAHI) and sleep staging identification (bSTAGES).
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K Number
K211407Device Name
Belun Ring BLR-100X
Manufacturer
Belun Technology Company Limited
Date Cleared
2021-10-21
(168 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Belun Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms.
Device Description
Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does not have alarms. The proposed device consists of three parts: A Ring, a Cradle and a Host program. The Ring is intended to be worn on the base of the index finger. It provides comfortable and accurate measurements without the Cradle in the recording mode. The soft part of the Ring is designed to be changeable for fitting different sizes of fingers. The Cradle collects data from the Ring and charges up the Ring. It transfers the collected data to host via an attached USB cable or Bluetooth low power technology. The host program translates the data into text and graph which can be easily understood by the user. Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in the light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using light of two wavelengths: red and infrared. The ratio of absorbance at these wavelengths is calculated and calibrated against direct measurements of arterial oxygen saturation (SaO2) to establish the pulse oximeter's measurement of functional oxygen saturation of arterial hemoglobin (SpO2). The sensor of the Ring should be placed on the palmar side of the proximal phalanx of the index finger and along the radial artery. The system consists of three main platforms. Ring is responsible for signal acquisition, data processing, parameters calculation (SpO2/PR algorithm), sensor interfacing and user interface. Cradle takes care of the data storage, data transfer and user interface. Host program is for data export and user interface. The system includes two embedded software and one host program, namely the Ring firmware, the Cradle firmware and the Belun Ring Management.
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K Number
K191417Device Name
Belun Ring
Manufacturer
Belun Technology Company Limited
Date Cleared
2019-10-10
(135 days)
Product Code
DQA, DOA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Belun Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, intended to be used for spot-checking and/or data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment. It is not intended for single-use and out-of-hospital transport use.
Device Description
The proposed device Belun Ring BLR-100C is a non-invasive and stand-alone pulse oximeter, which can detect, display and transfer the measured oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate in hospital and home environment.
The proposed device consists of two parts: A Ring and a Cradle.
The Ring, which is of a smooth and a light design and is easy to be worn and taken off, is intended to be worn on the base of the index finger. It provides comfortable and accurate measurements with the Cradle in the spot-checking mode or without the Cradle in the recording mode. The Cradle collects data from the Ring and translates the data into text and graph which can be easily understood by the user. It also exports the collected data via USB port to a host such as computer or mobile equipment for recording data transfer and review. They usually outside of patient environment, which is remote from the patient. There is no wireless function in this device.
Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in the light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using light of two wavelengths: red and infrared. The ratio of absorbance at these wavelengths is calculated and calibrated against direct measurements of arterial oxygen saturation (SaO2) to establish the pulse oximeter's measurement of functional oxygen saturation of arterial hemoglobin (SpO2). The sensor of the Ring should be placed on the palmar side of the proximal phalanx of the index finger and along the radial artery.
The system is using a customized dual CPU design to realize the functions. It consists of two main platforms: The Ring is responsible for signal pre-conditioning, data post-processing (SPO2/PR algorithm), parameters calculation and sensor interfacing, while the Cradle takes care of the user interface including a display for output and a button for input.
The system includes two embedded software, namely the Ring firmware and the Cradle firmware. It is modularized and provides high stability. The software systems work in conjunction with the Ring and the Cradle. The two platforms (Ring and Cradle) are connected via "Connectivity software module". The communication protocol is proprietary which provides a reliable and fast communication.
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K Number
K180174Device Name
Belun Ring
Manufacturer
Belun Technology Company Limited
Date Cleared
2018-05-29
(127 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
Belun Technology Company Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, intending for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment. It is not intended for single-use and out-of-hospital transport use.
Device Description
The proposed device Belun Ring BLR-100 is a non-invasive and stand-alone pulse oximeter, which can detect and display the measured oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate in hospital and home environment.
The proposed device consists of two parts: Ring and Cradle.
The Ring is intended to be worn on the bottom of index finger. The Cradle collects data from the ring and translates it into text and graph for the user.
Using spectrophotometric methodology, the proposed device measures oxygen saturation by illuminating the skin and measuring changes in light absorption of oxygenated (oxyhemoglobin) and deoxygenated blood (reduced hemoglobin) using two-wavelengths light: red and infrared. The ratio of absorbance at these wavelengths is calculated and calibrated against direct measurements of arterial oxygen saturation (SaO2 ) to establish the pulse oximeter's measurement of functional oxygen saturation of arterial hemoglobin (SpO2 ). The sensor of the Ring should be placed on palmar side of the proximal phalanx of the index finger and the sensor is being place along the radial artery. The system uses a customized dual CPU design. It consists of two main platforms: the Ring is responsible for signal pre-conditioning, data post-processing (SPO2/PR algorithm), parameters calculation and sensor interfacing, while the Cradle takes care of the user interface including display output and button user input.
The system includes two embedded software, namely Ring firmware and Cradle firmware. The software systems work in conjunction with Ring and Cradle. The two platforms (Ring and Cradle) are connected via "Connectivity software module". The communication protocol is proprietary which provides a reliable and fast communication.
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