Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017486514

FEI Number

3017486514

Entity Name

UMANO MEDICAL INC

City/State/Country

Levis Quebec, CA

Establishment Address

470, 3e Avenue, Levis Quebec G6W 5M6, CA

Establishment Type(s)

Manufacture Medical 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

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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2015-04-09
IOQ	Bed, Flotation Therapy, Powered	Physical Medicine	Class 2	890.5170	2021-04-28

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
3043625036	Umano Medical Inc.	Sherbrooke Quebec, CA
3009591865	UMANO MEDICAL INC	L Islet Quebec, CA

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K890935	Dermanetics Corp.	SYSTEM 3000 FLUIDIZED AIR BED	1989-03-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017486514. Last updated year: 2026. Please use registration number 3017486514 when referencing this establishment in official correspondence.