FDA.reportPublic FDA data

Thevo Flex FR 140kg, 105x200cm, jersey white

Primary DI
04034089098623
Brand
Thevo Flex FR 140kg, 105x200cm, jersey white
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800679150044
Published
2024-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04034089098623PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089098623040340890986234034089098623

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bed mattressA large, durable, fabric case filled with a combination of layered resilient materials (e.g., foam rubber and gel) designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie and rest/sleep, and to promote therapeutic postures in users suffering back maladies (e.g., spinal column compression, back pain) through the homogenous distribution of body weight.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
317356343
Device count
1
Premarket exempt
true
Serial number
true

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
04034089107745Swifty 3 Reha-Buggy (LB)98000680901002026-05-26
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
H93352765Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
H93363822Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2026-08-25
00817012020229K-11KAP MEDICALIKY2026-08-21
00810055884414MATT 35X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884421MATT 35X80 ELITE 500-G LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588443835X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884445MATT 35X76 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884452MATT 42X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884469MATT 42X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884476MATT 35X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884483MATT 35X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884490MATT 35X80 BASIC STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884506MATT 35X76 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884513MATT 35X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588452035X84 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884537MATT 42X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884544MATT 35X76 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884551MATT 36X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884568MATT 36X80 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884575MATT 35X80 ELITE-G 600 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884582MATT 35X76 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884599MATT 35X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884612MATT 42X80 ELITE-G SW 500 STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884636MATT 39X80 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884643MATT 42X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884674MATT 36X80 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884681MATT 42X84 ELITE-G 500 LBS STR ZIP COV CJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884704MATT 42X84 DELUXE STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
00810055884711MATT 35X84 DELUXE SW STR ZIP COV CAJOERNS HEALTHCARE, LLCIKY2026-08-16
0081005588472836X80 ELITE-G 500 STR ZIP COV INC BAR,CAJOERNS HEALTHCARE, LLCIKY2026-08-16