FDA.reportPublic FDA data

Comfort

Primary DI
05999569240048
Brand
Comfort
Company
DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű Társaság
Model
Comfort-4 Plus
Catalog number
723C4P02
Device description
An electrically powered thearpy chair used to position the patient in a sitting, semi-sitting, or reclined posture for easy access and patient comfort during an examination, treatment, or surgical intervention.
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GBBChair, Surgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBBChair, Surgical, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05999569240048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05999569240048059995692400485999569240048

GMDN Terms#

Term, Definition table
TermDefinition
General examination/treatment chair, electricA mains electricity (AC-powered) device designed to support and position the patient in a seated or reclined posture for easy access and patient comfort during a diagnostic examination, medical treatment, and/or surgical procedure across specialties. It usually has moveable components and may include special features such as a raising and lowering mechanism and removable arms; it may have an integrated weighing scale. For chairs involving the use of medical systems that emit and/or detect energy (e.g., ionizing or non-ionizing radiation, ultrasound, heat, light) see the respective chair terms for those systems.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight87Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Degrees Celsius80 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3637311990quality@digiterm.hu

Regulatory Flags#

DUNS number
401512397
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05999569240079Comfort Comfort-1 Recliner723C1R012026-03-24
05999569242202Comfort Comfort-2 Eco723C2E012026-03-24
05999569242219Comfort Comfort-2 Flex23C2F012026-03-24
05999569244213Comfort Comfort-4 Battery723C4B012026-03-24
05999569245005DiacareDiacare 3713DC3002026-03-24
05999569240024Comfort Comfort-1 Eco723C1E012025-04-22
05999569243209Comfort Comfort-3 ECO723C3E012025-04-22
05999569243216Comfort Comfort-3 Flex723C3F012025-04-22
05999569244206Comfort Comfort-4 Eco723C4E012025-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08600155032011DexorRappo Robotics, Inc.GBB2026-05-16
M368EPC500ST1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-04-09
M368EPC500STMB1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-04-09
05999569240079Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242202Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569242219Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569244213Comfort DIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
05999569245005DiacareDIGITERM Műszaki Fejlesztő, Gyártó és Kereskedelmi Korlátolt Felelősségű TársaságGBB2026-03-24
07350136560217Pedal platformRini Ergoteknik ABGBB2026-03-24
M368ESC2EYESTMBX1HAUSTEDGF HEALTH PRODUCTS, INC.GBB2026-02-02
04049199006277SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006284SCHMITZSCHMITZ medical GmbHGBB2025-09-17
04049199006291SCHMITZSCHMITZ medical GmbHGBB2025-09-17
M368ESC2EYESTMB1HaustedGF HEALTH PRODUCTS, INC.GBB2025-08-21
04049199011608SCHMITZSCHMITZ medical GmbHGBB2025-08-14
00840183530372BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
00840183530389BR Surgical, LLCBR Surgical, LLCGBB2025-07-16
00841709122958MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122965MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122972MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122989MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709122996MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123009MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123016MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123023MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123030MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123047MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123054MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123061MidmarkMIDMARK CORPORATIONGBB2025-06-04
00841709123078MidmarkMIDMARK CORPORATIONGBB2025-06-04