FDA.reportPublic FDA data

"ThevoCalm FR 308 lbs, Split King 38x79"", inco grey"

Primary DI
04034089093758
Brand
"ThevoCalm FR 308 lbs, Split King 38x79"", inco grey"
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800673140024
Published
2023-04-28
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
04034089093758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089093758040340890937584034089093758

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
04034089098623Thevo Flex FR 140kg, 105x200cm, jersey white98006791500442024-04-11
04034089098340ThevoRelief FR 100 100x190 Inko, grey98006930400142024-03-28

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
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