FDA.reportPublic FDA data

A-chassis, size 1, folding aluminum frame, adjustable, 2 swivel wheels, tilt-in-

Primary DI
04034089051512
Brand
A-chassis, size 1, folding aluminum frame, adjustable, 2 swivel wheels, tilt-in-
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800062022000
Published
2022-07-11
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
04034089051512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089051512040340890515124034089051512

GMDN Terms#

Term, Definition table
TermDefinition
Assistive pushchairA wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317356343
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
false
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
04034089107745Swifty 3 Reha-Buggy (LB)98000680901002026-05-26
04034089098623Thevo Flex FR 140kg, 105x200cm, jersey white98006791500442024-04-11
04034089098340ThevoRelief FR 100 100x190 Inko, grey98006930400142024-03-28
040340890953875 point belt, 25mm (Advantage, Swifty)98000848000002023-12-14
04034089096698ThevoautoActive FR 297 lbs, Split King 38x79", inco lip.98006851100142023-12-13
04034089096735ThevoRelief FR 220 lbs, 38 x 79"" (Split King), Inco grey98006931400242023-12-13
04034089093284Under seat storage basket Swifty98000681310002023-07-03
04034089094021ThevoautoActiv FR 110 lbs, Split King 38x79", inco grey98006811000142023-06-06
04034089089287Pneumatic wheels A-chassis, full set98000664701002022-07-19
04034089088235ThevoRelief FR 110 lbs, Hospital size 36x79", inco grey98006910000142023-04-28
04034089088327ThevoFlex FR 308 lbs, Twin size 39x75", inco grey98006780200142023-04-28
04034089089263Pneumatic tires retrofit kit (Swifty 2)98000667110002023-04-28
04034089089294Pneumatic wheels Advantage chassis, full set98000664711002023-04-28
04034089090238ThevoCalm FR 308 lbs, Twin size 39x75", inco grey98006730400142023-04-28
04034089092362ThevoVital FR 176 lbs, Full size 54x75”, jersey white98006282500442023-04-28
04034089092379ThevoVital FR 308 lbs, Full size 54x75", jersey white98006288300442023-04-28
04034089092386ThevoCalm FR 176 lbs, Full size 54x75", jersey white98006720900442023-04-28
04034089092393ThevoCalm FR 308 lbs, Full size 54x75", jersey white98006740700442023-04-28
04034089092409ThevoRelief FR 110 lbs, Full size 54x75”, jersey white98006920800442023-04-28
04034089092416ThevoRelief FR 220 lbs, Full size 54x75", jersey white98006941300442023-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
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