ROHO Dual Compartment Cushion

GUDID 00613732053345

Modified configuration of a ROHO Dual Compartment Cushion. It may be any size and include high, mid, or low profile cells.

Roho, Inc.

Air-filled chair cushion
Primary Device ID00613732053345
NIH Device Record Keye86353bb-b228-41c3-b13d-74b3aa2017e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameROHO Dual Compartment Cushion
Version Model Number2RMODIFIED
Company DUNS006614792
Company NameRoho, Inc.
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
GS100613732053345 [Primary]

FDA Product Code

KICCushion, Flotation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-05
Device Publish Date2022-11-25

Devices Manufactured by Roho, Inc.

00613732113599 - ROHO QUADTRO SELECT MID PROFILE Cushion2025-03-24
00613732113612 - ROHO QUADTRO SELECT MID PROFILE Cushion2025-03-24
00613732113636 - ROHO QUADTRO SELECT MID PROFILE Cushion2025-03-24
00613732113650 - ROHO ENHANCER Cushion2025-03-24
00613732113674 - ROHO ENHANCER Cushion2025-03-24
00613732114022 - ROHO LOW PROFILE Single Compartment Cushion 2025-03-24
00613732114046 - ROHO LOW PROFILE Single Compartment Cushion 2025-03-24
00613732114060 - ROHO LOW PROFILE Single Compartment Cushion 2025-03-24

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.