Rhythm Healthcare, LLC LM5BA

GUDID 00860014866548

The Rhythm Healthcare LM5BA is a stationary (home-use) continuous-flow oxygen concentrator designed to provide supplemental oxygen therapy in residential, nursing home or other non-acute care settings. The device uses the pressure swing adsorption (PSA) principle to separate oxygen from ambient air via molecular sieve beds. The LM5BA delivers oxygen at a continuous flow rate of up to 5 liters per minute, with an output oxygen concentration of approximately 93% ± 3% under rated conditions. The device is intended for use by adult, geriatric, and pediatric patients under the prescription and supervision of a qualified physician. It is not intended to sustain or support life in the sense of life-support systems. Key features include a user-friendly control panel, audible and visual alarms for temperature, oxygen purity, high/low pressure, power failure and blockage, low noise operation, high output pressure design, and optional accessories such as a transfill rack. Typical specifications: • Flow rate: up to 5

Rhythm Healthcare, LLC

Mobile/portable oxygen concentrator

• Primary Device ID: 00860014866548
• NIH Device Record Key: e590cc27-8136-40de-9f1b-346bbd1f8cb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythm Healthcare, LLC
• Version Model Number: LM5BA
• Catalog Number: LM5BA
• Company DUNS: 117783267
• Company Name: Rhythm Healthcare, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com
• Phone: 8139475334
• Email: uunderwood@rhythmhc.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014866548 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102245

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-20
• Device Publish Date: 2025-11-12

Devices Manufactured by Rhythm Healthcare, LLC

• 00860014866548 - Rhythm Healthcare, LLC: 2025-11-20The Rhythm Healthcare LM5BA is a stationary (home-use) continuous-flow oxygen concentrator designed to provide supplemental oxygen therapy in residential, nursing home or other non-acute care settings. The device uses the pressure swing adsorption (PSA) principle to separate oxygen from ambient air via molecular sieve beds. The LM5BA delivers oxygen at a continuous flow rate of up to 5 liters per minute, with an output oxygen concentration of approximately 93% ± 3% under rated conditions. The device is intended for use by adult, geriatric, and pediatric patients under the prescription and supervision of a qualified physician. It is not intended to sustain or support life in the sense of life-support systems. Key features include a user-friendly control panel, audible and visual alarms for temperature, oxygen purity, high/low pressure, power failure and blockage, low noise operation, high output pressure design, and optional accessories such as a transfill rack. Typical specifications: • Flow rate: up to 5
• 00860014866548 - Rhythm Healthcare, LLC: 2025-11-20 The Rhythm Healthcare LM5BA is a stationary (home-use) continuous-flow oxygen concentrator designed to provide supplemental oxyg
• 06978651650070 - RHYTHM HEALTHCARE: 2025-09-09 The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation uni
• 06971072050122 - Rhythm: 2025-02-13
• 06971072050115 - Rhythm Healthcare: 2024-09-11 The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation uni