FDA.reportPublic FDA data

Simplex bath chair

Primary DI
04034089082196
Brand
Simplex bath chair
Company
Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Model
9800021602000
Published
2022-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KTCBath, Sitz, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTCBath, Sitz, NonpoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04034089082196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04034089082196040340890821964034089082196

GMDN Terms#

Term, Definition table
TermDefinition
Bathing/changing table, mobileA raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off) mounted on a foldable frame with legs designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff). The device is used primarily for a patient with a disability incapable of supporting themself in an upright position for bathing. It is designed to be portable or easily moved on wheels to different locations.

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
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
04034089096698"ThevoautoActive FR 297 lbs, Split King 38x79"", inco lip."98006851100142023-12-13
04034089096735"ThevoRelief FR 220 lbs, 38 x 79"""" (Split King), Inco grey"98006931400242023-12-13
04034089093284Under seat storage basket Swifty98000681310002023-07-03
04034089094021"ThevoautoActiv FR 110 lbs, Split King 38x79"", inco grey"98006811000142023-06-06
04034089089287Pneumatic wheels A-chassis, full set98000664701002022-07-19
04034089088235"ThevoRelief FR 110 lbs, Hospital size 36x79"", inco grey"98006910000142023-04-28
04034089088327"ThevoFlex FR 308 lbs, Twin size 39x75"", inco grey"98006780200142023-04-28
04034089089263Pneumatic tires retrofit kit (Swifty 2)98000667110002023-04-28
04034089089294Pneumatic wheels Advantage chassis, full set98000664711002023-04-28
04034089090238"ThevoCalm FR 308 lbs, Twin size 39x75"", inco grey"98006730400142023-04-28
04034089092362ThevoVital FR 176 lbs, Full size 54x75”, jersey white98006282500442023-04-28
04034089092379"ThevoVital FR 308 lbs, Full size 54x75"", jersey white"98006288300442023-04-28
04034089092386"ThevoCalm FR 176 lbs, Full size 54x75"", jersey white"98006720900442023-04-28
04034089092393"ThevoCalm FR 308 lbs, Full size 54x75"", jersey white"98006740700442023-04-28
04034089092409ThevoRelief FR 110 lbs, Full size 54x75”, jersey white98006920800442023-04-28
04034089092416"ThevoRelief FR 220 lbs, Full size 54x75"", jersey white"98006941300442023-04-28

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Primary DI, Brand, Company table
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07350016061537TR900CWA HI LO 110V Cleaning, Autofill & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061544TR900CW Fixed height 230VTr Equipment ABKTC2023-12-12
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