ThevoCalm FR 176 lbs, Split King 38x79", jersey white

GUDID 04034089092638

Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress Orthopaedic bed mattress
Primary Device ID04034089092638
NIH Device Record Keyf12bafae-69a8-4753-99f5-9a5d100f72ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameThevoCalm FR 176 lbs, Split King 38x79", jersey white
Version Model Number9800672160044
Company DUNS317356343
Company NameThomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104034089092638 [Primary]

FDA Product Code

IKYMattress, Flotation Therapy, Non-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-08
Device Publish Date2023-04-28

Devices Manufactured by Thomas Hilfen für Körperbehinderte GmbH & Co. Medico Kommanditgesellschaft

04034089098623 - Thevo Flex FR 140kg, 105x200cm, jersey white2024-04-19
04034089098340 - ThevoRelief FR 100 100x190 Inko, grey2024-04-05
04034089095387 - 5 point belt, 25mm (Advantage, Swifty)2023-12-22
04034089096698 - ThevoautoActive FR 297 lbs, Split King 38x79", inco lip.2023-12-21
04034089096735 - ThevoRelief FR 220 lbs, 38 x 79"" (Split King), Inco grey2023-12-21
04034089093284 - Under seat storage basket Swifty2023-07-11
04034089094021 - ThevoautoActiv FR 110 lbs, Split King 38x79", inco grey2023-06-14
04034089089287 - Pneumatic wheels A-chassis, full set2023-06-07

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.