Rhythm Healthcare

Primary DI
00850083102319
Brand
Rhythm Healthcare
Company
Rhythm Healthcare, LLC
Model
LM10A
Catalog number
J10A
Device description
The Oxygen Concentrator provides supplemental oxygen to patients who require supplemental O2, by separating nitrogen from room air,by way of a molecular sieve through a pressure swing adsorption work principle, it can be used in the home or healthcare facility. It is not intended to sustain or support life.J10A is equivalent to ZY-10AB/115. Trade or Catalog Name is J10A or LM10A
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
CAWGenerator, Oxygen, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAWGenerator, Oxygen, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251534000Oxygen Concentrator (J10A)Foshan Kycare Medical Equipment Co., Ltd.2025-12-29CAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083102319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083102319008500831023198500831023190850083102319

GMDN Terms#

Term, Definition table
TermDefinition
Mobile/portable oxygen concentratorA mobile/portable mains electricity (AC-powered) device designed to concentrate oxygen (O2) from ambient air and deliver the concentrated O2, typically through an attached nasal cannula, to a patient requiring oxygen therapy. It processes the air through an internal filtration system, e.g., a molecular sieve (zeolite granules or membranes), having a large total surface area to separate nitrogen (N2) from the air. It typically consists of an air compressor, filters, dual chambers, a reservoir and controls. The O2 concentration is variable depending on the flow rate utilized. It is used in a home, institution, or a vehicle and typically has internal batteries for transportable use.

Regulatory Flags#

DUNS number
117783267
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083102944Rhythm Healthcare, LLCLM5BAJ5A2026-04-24
00860014866548Rhythm Healthcare, LLCLM5BALM5BA2025-11-12
06978651650070RHYTHM HEALTHCARELM5BA2025-09-01
06971072050122RhythmLM10AZY-10AB/1152025-02-05
06971072050115Rhythm HealthcareLM5BA2024-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447114635Invacare® Platinum Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00841447114642Invacare® Perfecto2V Oxygen ConcentratorINVACARE CORPORATIONCAW2026-07-21
00810178889624Vive BreatheVIVE HEALTH LLCCAW2026-06-01
00810178885756ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885763ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885770ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885787ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885794ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885800ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885817ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00810178885824ViveBreatheVIVE HEALTH LLCCAW2026-04-26
00850083102944Rhythm Healthcare, LLCRhythm Healthcare, LLCCAW2026-04-24
15060031380191RUGGED OXYGEN GENERATOR (ROG)MOLECULAR PRODUCTS LIMITEDCAW2026-04-21
00810178884452ViveBreatheVIVE HEALTH LLCCAW2026-01-30
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M766AS200SW30FreeStyle Comfort CAIRE INC.CAW2020-08-06
00885304032502DeVilbissDEVILBISS HEALTHCARE LLCCAW2020-05-27
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