FDA.reportPublic FDA data

Rhythm Healthcare, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30029425063002942506Rhythm Healthcare, LLC1Y2026-01-0113577 Feather Sound Dr Ste 100 Clearwater FL US 33762
30147774233014777423RHYTHM HEALTHCARE LLC RHYTHM HEALTHCARE LLC1N2026-01-011550 Magnolia Ave Suite 104 Corona Ca 92879 Corona CA US 92879

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860014866548Rhythm Healthcare, LLC - 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 58139475334uunderwood@rhythmhc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2356391152560125K251764Oxygen Concentrator-P2-O5ECAW2025-12-22
2356391888342332K242718Portable Oxygen Concentrator (P2-TOC)CAW2025-02-28
2356391765251307K230702Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)CAW2023-10-18
2356391010585529K223379Portable Oxygen Concentrator (Model: P2-E7, P2-E)CAW2023-06-22
2356391239987912K210371Portable Oxygen Concentrator, model: P2-E6CAW2022-06-03
2356391937429869K190304Kingon P2 Oxygen ConcentratorCAW2020-02-29
2356391117343589
1125331808083519

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAW62025-12-22

GUDID#

Rhythm Healthcare, LLC - 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

2025-11-12

RHYTHM HEALTHCARE - The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation unit which is based on molecular sieves selective adsorption of nitrogen from air. It can continuously generate oxygen with the purity 93%±3% at ambient temperature. The adsorbed nitrogen can be desorbed by decreasing the adsorbed bed pressure resulting cyclical adsorption-desorption operation. The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it’s not intended to support or sustain life.

Rhythm Healthcare, LLC

2025-09-01

Rhythm Healthcare - The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation unit which is based on molecular sieves selective adsorption of nitrogen from air. It can continuously generate oxygen with the purity 93%±3% at ambient temperature. The adsorbed nitrogen can be desorbed by decreasing the adsorbed bed pressure resulting cyclical adsorption-desorption operation. The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it’s not intended to support or sustain life.

Rhythm Healthcare, LLC

2024-09-03