FDA.reportPublic FDA data

RC CareChair 650

Primary DI
00857268006783
Brand
RC CareChair 650
Company
JOERNS HEALTHCARE, LLC
Model
RCCC650B
Published
2017-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYNChair, Posture, For Cardiac And Pulmonary Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYNChair, Posture, For Cardiac And Pulmonary TreatmentAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857268006783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857268006783008572680067838572680067830857268006783

GMDN Terms#

Term, Definition table
TermDefinition
Mobile bariatric examination/treatment chair, electricA mobile (on wheels) electronic device designed to support in a seated position an ambulatory or non-ambulatory bariatric (obese) patient, whose body mass exceeds the safe working load of a standard hospital/institution chair (e.g., around 350 kg), for examination/treatment. It incorporates a heavy-duty framework, extra wide seat-support for the patient, and an integrated rechargeable battery pack that powers electromotive functions (e.g., raise/lower/tilt/adjustment functions, motorized wheels). It is designed to be moved by healthcare professional for patient transport to a site for patient support without transfer during outpatient examination/treatment (e.g., surgical, dental, ENT).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-826-0270xxx@xxx.xxx

Regulatory Flags#

DUNS number
790937150
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055880126SlingsNA25705NA257052025-07-22
00810055884865Dolphin Fluid Immersion SimulationDLPH-3382OOEUJ-MDLPH-3382OOEUJ-M2025-07-10
00857268006707Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2025-07-10
00857268006851Dolphin Fluid Immersion SimulationDLPH-4882LPOOJ-MDLPH-4882LPOOJ-M2025-07-10
00857268006875Dolphin Fluid Immersion SimulationDLPH-3582OO4WJ-MDLPH-3582OO4WJ-M2025-07-10
00857268006752Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-CDLPH-1717WCOOJ-C2025-07-08
00857268006295Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-MDLPH-3582OOOOJ-M2025-07-07
00857268006257Dolphin Fluid Immersion SimulationFIS Step-deckDLPH-3588OVOOJ-M2016-09-06
00857268006417Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-M2016-09-02
00810055884834Panacea - DSPAN1000-FLEX-RILG2PAN1000-FLEX-RILG22025-06-18
00810055884841Panacea - DSPAN1K-FLEX-RILG2QSPAN1K-FLEX-RILG2QS2025-06-18
00810055884858Panacea - DSPAN1000-FLEX-RAHG2PAN1000-FLEX-RAHG22025-06-18
00857268006868Dolphin FISDLPP-2850CBJ-MDLPP-2850CBJ-M2025-05-29
00857268006271Dolphin Fluid Immersion SimulationDLPH-3582OOOOJ-M2017-08-22
00857268006424Dolphin Fluid Immersion SimulationDLPH-3582LPOOOJ-MDLPH-3582LPOOOJ-M2016-09-02
00857268006714Dolphin Fluid Immersion SimulationDLPH-4882OOOOJ-M2017-08-22
00857268006318Dolphin Fluid Immersion SimulationDLPH-4282OOOOJ-M2017-08-22
00857268006394Dolphin Fluid Immersion SimulationFIS StretcherDLPH-3176OSOOJ-P2016-09-02
00857268006400Dolphin Fluid Immersion SimulationDLPH-1717WCOOJ-C2016-09-02
00857268006455Dolphin Fluid Immersion SimulationDLPH-4282LPOOJ-MDLPH-4282LPOOJ-M2016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857268006776RC CareChair 550JOERNS HEALTHCARE, LLCBYN2017-10-05
00857268006790RC CareChair 850JOERNS HEALTHCARE, LLCBYN2017-10-05