FDA.reportPublic FDA data

R82

Primary DI
05707292760609
Brand
R82
Company
R82 A/S
Model
x:panda SIZE-1
Catalog number
X8910111-02
Published
2022-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INNCHAIR, ADJUSTABLE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707292760609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707292760609057072927606095707292760609

GMDN Terms#

Term, Definition table
TermDefinition
Assistive ergonomic chair, manually-adjustedA non-electrical device, that may include pneumatically-assisted features, intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with manually-operated ergonomic adjustments (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
308022169
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05715393022809R82Addax SIZE 19120010002026-01-20
05715393022816R82Addax SIZE 19120010012026-01-20
05715393022823R82Addax SIZE 29120020002026-01-20
05715393022830R82Addax SIZE 29120020012026-01-20
05715393012275R82Flamingo Curo SIZE-18820012025-09-01
05715393012282R82Flamingo Curo SIZE-28820022025-09-01
05715393012299R82Flamingo Curo SIZE-38820032025-09-01
05715393021949R82Crocodile, Size 1 AT86801AT2025-05-15
05715393021956R82Crocodile, Size 2 AT86802AT2025-05-15
05715393021963R82Crocodile, Size 3 AT86803AT2025-05-15
05715393021970R82Crocodile, Size 1 AT86801AT-ATS2025-05-15
05715393021987R82Crocodile, Size 2 AT86802AT-ATS2025-05-15
05715393022014R82Crocodile, Size 3 AT86803AT-ATS2025-05-15
05715393013982R82Meerkat SIZE-1870011-1RS2024-09-13
05715393013999R82Meerkat SIZE-1870011-2RS2024-09-13
05715393014002R82Meerkat SIZE-2870022-RS2024-09-13
05715393014019R82Meerkat SIZE-3870023-RS2024-09-13
05707292975003R82Chilla SIZE 18811111002024-08-14
05707292975027R82Chilla SIZE 18811111102024-08-14
05707292975041R82Chilla SIZE 18811111202024-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
00628758009009ZwimRaz Design IncINN2024-11-06
00850010988702Mor-Medical New EraMoroles Investments, LLCINN2024-07-16
10197344018840MEDLINEMEDLINE INDUSTRIES, INC.INN2024-06-26
00628758001027JazRaz Design IncINN2024-06-12
00628758002024JazRaz Design IncINN2024-06-12
05056235203858Jenx JENX LIMITEDINN2024-05-10
05056235203865Jenx JENX LIMITEDINN2024-05-10
05056235203872Jenx JENX LIMITEDINN2024-05-10
05056235203889Jenx JENX LIMITEDINN2024-05-10
05056235203896Jenx JENX LIMITEDINN2024-05-10
05056235203902Jenx JENX LIMITEDINN2024-05-10
05056235203919Jenx JENX LIMITEDINN2024-05-10