FDA.reportPublic FDA data

Swifty 3 Reha-Buggy (LB)

Primary DI
04034089107745
Brand
Swifty 3 Reha-Buggy (LB)
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800068090100
Published
2026-05-26
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
04034089107745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089107745040340891077454034089107745

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.

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
04034089093246Abduction block (Hercules Prime, Swifty 398000041210002026-05-29
04034089097640crotch pad with magnetic lock (Hercules Prime)98000043400002026-05-29
04034089103334Back cushion, seat reducer (Swifty 3)98000695900002026-05-29
04034089103341Seat minimizer Swifty 398000696000002026-05-29
04034089103358Seat width reducer Swifty 398000695800002026-05-29
04034089103365Lateral trunk supports, swing-away, Swifty 398000695700002026-05-29
04034089103372Lateral head supports, Swifty 398000695500002026-05-29
04034089103402Frame padding Swifty 398000696500002026-05-29
04034089103419Canopy Swifty 398000696300002026-05-29
04034089103433Rain poncho Swifty 398000696400002026-05-29
04034089103464Pneumatic wheels, set, Swifty 398000696600002026-05-29
04034089103471under seat storage bag Swifty 398000697100002026-05-29
04034089103488under seat storage basket Swifty 398000697000002026-05-29
04034089103495Lateral trunk supports, rigid, Swifty 398000695600002026-05-29
04034089103501Drum brake, set, Swifty 398000696700002026-05-29
04034089103648Chin support rehab98000056200002026-05-29
04034089104010Incontinence Seat Cover size L98000696100002026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05715393055838R82R82 A/SINN2026-03-26
05715393078868R82R82 A/SINN2026-03-26
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
00860014545825Peri-Chair LLCPERI-CHAIR, LLCINN2025-10-15
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
05707581000751Shower SeatRopox A/SINN2022-12-08
05707581000768Shower SeatRopox A/SINN2022-12-08
05707581000775Shower SeatRopox A/SINN2022-12-08
05707581000782Shower SeatRopox A/SINN2022-12-08
07320451321794Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451321817Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451351173Etac Supply Center ABEtac Supply Center ABINN2022-12-08
00850001752169Compass Chair Size 1RIFTON EQUIPMENTINN2022-09-16
00850001752176Compass Chair Size 2RIFTON EQUIPMENTINN2022-09-16