Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009591865

FEI Number

3009591865

Entity Name

UMANO MEDICAL INC

City/State/Country

L Islet Quebec, CA

Establishment Address

230 Boulevard Nilus-Leclerc, L Islet Quebec G0R 2C0, CA

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Umano Medical Inc (Owner Number: 10040948)

Owner / Operator Contact Address

230 Boulevard Nilus-Leclerc, L'Islet, CA-QC G0R 2C0, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Model Number FTG FTG Overbed table Series Curbell Bed Interconnect Cables OOK SNOW FL36 OOK COCOON OOK SNOW MH 200-0000 OOK SNOW ALL Accessories: UMANO CONNECT, TRASNPORT SHELF, UmanoLocation, REMOVABLE PATIENT CONTROL , PATIENT HELPER. comfortNEST greenXi comfortNEST blue+ comfortNEST green MH comfortNEST green oneNEST comfortNEST yellow MH comfortNEST yellow comfortNEST blue comfortNEST blue MH comfortNEST yellow+ comfortNEST green+ oneNEST S oneNEST M Control unit oneNEST M airNEST orange airNEST orangeXi airNEST orange Hybrid

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2012-06-08
ISN	Cable	Physical Medicine	Class 1	890.3420	2022-09-07
KMN	Chair And Table, Medical	General Hospital	Class 1	880.6140	2013-01-09
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2012-06-05
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2015-04-09
IQA	System, Environmental Control, Powered	Physical Medicine	Class 2	890.3725	2015-12-28
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2021-04-28
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	2016-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

Umano Medical Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3017486514	UMANO MEDICAL INC	Levis Quebec, CA
3043625036	Umano Medical Inc.	Sherbrooke Quebec, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009591865. Last updated year: 2026. Please use registration number 3009591865 when referencing this establishment in official correspondence.