FDA.reportPublic FDA data

ThevoRelief FR 100 100x190 Inko, grey

Primary DI
04034089098340
Brand
ThevoRelief FR 100 100x190 Inko, grey
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800693040014
Published
2024-03-28
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
04034089098340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089098340040340890983404034089098340

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
Lot or batch
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
04034089098623Thevo Flex FR 140kg, 105x200cm, jersey white98006791500442024-04-11
040340890953875 point belt, 25mm (Advantage, Swifty)98000848000002023-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887761010901Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010918Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
00887761010925Stretcher SurfaceHILL-ROM, INC.IKY2026-02-19
05059441461654TherarestArjohuntleigh ABIKY2026-02-10
00810178885084ViveVIVE HEALTH LLCIKY2026-02-02
00810178885091ViveVIVE HEALTH LLCIKY2026-02-02
H93353893Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-12-01
08592654851067Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851074Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
08592654851081Ergozone 3000L I N E T spol. s r.o.IKY2025-11-03
00841447115175Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115182Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115199Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
00841447115205Invacare® Softform Premier Foam MattressINVACARE CORPORATIONIKY2025-10-10
05056147701497Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701503Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701510Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701527Accora Allevia ComfortACCORA LIMITEDIKY2025-09-30
05056147701534Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701541Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701558Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701565Accora Allevia PrimaACCORA LIMITEDIKY2025-09-30
05056147701572Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701589Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701596Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
05056147701602Accora Allevia ClassicACCORA LIMITEDIKY2025-09-30
H93331629Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93313584Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-09-04
H93335834Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04
H93338296Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-08-04