FDA.reportPublic FDA data

ThevoRelief FR 220 lbs, Full size 54x75", jersey

Primary DI
04034089066998
Brand
ThevoRelief FR 220 lbs, Full size 54x75", jersey
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800694130004
Published
2022-07-13
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
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
04034089066998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089066998040340890669984034089066998

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
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
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
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
00841447115151Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-30
00841447115137Invacare Solace MattressINVACARE CORPORATIONIKY2025-06-23
H933MX8435NZ29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8036RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436RP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-04-22
H933PR8436FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-03-12
H933PR8036FP29Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2025-02-07
00840828193887BED MAT-7X36X88-CEN CORE-FOAM-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
00840828193894BED MAT-7X36X88-CENPROAF-PCCURBELL MEDICAL PRODUCTS, INC.IKY2025-01-08
H933UMX884829Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-12-03
00092237616246MERIDIAN MEDICALCOMPASS HEALTH BRANDS CORP.IKY2024-08-16
H93334371Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-08-13
00887761995116PROGRESSA+ ESSENTIAL SURFACEHill-Rom de México, S. de R.L. de C.V.IKY2024-07-12
00815067072941PROBASICSCOMPASS HEALTH BRANDS CORP.IKY2024-06-25
00841447114826Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114833Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114840Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
00841447114857Invacare EssentialsINVACARE CORPORATIONIKY2024-06-03
H933A803529B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03
H933A804229B0Span-AmericaSPAN-AMERICA MEDICAL SYSTEMS, INC.IKY2024-06-03