FDA.reportPublic FDA data

Rhapsody

Primary DI
05055982728560
Brand
Rhapsody
Company
Arjohuntleigh AB
Model
AR32212US1111
Catalog number
AR32212US1111
Device description
Bath System - Rhap Sys23 HM P220 Disp Des
Published
2024-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILJBath, hydro-massage

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILJBath, Hydro-MassagePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001079000RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMOArjo, Inc.2000-05-01ILJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055982728560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055982728560050559827285605055982728560

GMDN Terms#

Term, Definition table
TermDefinition
Hydrotherapy bath/tankA bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800) 323-1245us.info@arjo.com

Regulatory Flags#

DUNS number
355804758
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055982763035Maxi MoveKMCEUN2022-07-29
05055982763042Maxi MoveKMCEUN-D2022-07-29
05055982763059Maxi MoveKMCEXN2022-07-29
05055982763325Maxi MoveKMCEXN-D2022-07-29
05055982764407Maxi MoveKMCLUN2022-07-29
05055982764438Maxi MoveKMCLXNMAS000001-US2022-07-29
05055982764704Maxi MoveKMCLXN-C2022-07-29
05055982764971Maxi MoveKMCLXN-D2022-07-29
05055982766937Maxi MoveKMCSUN2022-07-29
05055982766944Maxi MoveKMCSUN-C2022-07-29
05055982766951Maxi MoveKMCSUN-D2022-07-29
05055982766968Maxi MoveKMCSXE2022-07-29
05055982767231Maxi MoveKMCSXE-C2022-07-29
05055982767507Maxi MoveKMCSXE-D2022-07-29
05055982767781Maxi MoveKMCSXN2022-07-29
05055982768054Maxi MoveKMCSXN-C2022-07-29
05055982768337Maxi MoveKMCSXN-D2022-07-29
05055982794619Maxi AirMAS000001-USMAS000001-US2022-07-30
15059441537295AIRPALAP-028SPNBLHAP-028SPNBLH2026-03-23
15059441537301AIRPALAP-034SPNB AP-034SPNB 2026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874983844Apollo CorpAPOLLO CORP.ILJ2025-11-17
05059441219576Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219583Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219590Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219606Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219613Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219620Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219637Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219644Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219651Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219668Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219675Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219682Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219699Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441219705Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268277Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268291Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441268307Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306108Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306115Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441306122Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310174Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310181Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310198Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310204Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310211Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310228Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310235Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310242Symbliss BathArjohuntleigh ABILJ2024-09-25
05059441310259Symbliss BathArjohuntleigh ABILJ2024-09-25