FDA.report

ThevoRelief FR 297 lbs, Split Queen 30x79"/ 75x200cm, jersey

Primary DI
04034089067346
Brand
ThevoRelief FR 297 lbs, Split Queen 30x79"/ 75x200cm, jersey
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800696100004
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

Related Records

Product Codes

CodeName
IKYMattress, Flotation Therapy, Non-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
IKYMattress, Flotation Therapy, Non-PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04034089067346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04034089067346040340890673464034089067346

GMDN Terms

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

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 DIBrandModelCatalogPublished
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
04034089092423ThevoRelief FR 297 lbs, Full size 54x75”, jersey white98006960900442023-04-28

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