Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021907521

FEI Number

3021907521

Entity Name

KWALU

City/State/Country

H. Matamoros Tamaulipas, MX

Establishment Address

Diagonal Lorenzo de la Garza # 9, Entre Norte 7 y Pedro Hinojosa, H. Matamoros Tamaulipas 87499, MX

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Kwalu (Owner Number: 10091047)

Owner / Operator Contact Address

6160 Peachtree Dunwoody Rd., Building C, Atlanta, GA 30328, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alesso Bed Frame, 36" Mattress Platform Alesso Bed Frame, 42" Mattress Platform Alesso Bed Frame, 42" Mattress Platform, Camelot Style Alesso Bed Frame, 42" Mattress Platform, Lancaster Style Alesso Bed Frame, 36" Mattress Platform, Camelot Style Alesso Bed Frame, 42" Mattress Platform, Atlanta Style Alesso Bed Frame, 36" Mattress Platform, Essex Style Alesso Bed Frame, 42" Mattress Platform, Atlanta Style, Upholstered Detail on Headboard Alesso Bed Frame, 42" Mattress Platform, Essex Style Alesso Bed Frame, 42" Mattress Platform, Dorchester Style Alesso Bed Frame, 36" Mattress Platform, Lancaster Style Alesso Bed Frame, 36" Mattress Platform, Atlanta Style Alesso Bed Frame, 36" Mattress Platform, Dorchester Style Alesso Bed Frame, 36" Mattress Platform, Atlanta Style, Upholstered Detail on Headboard Alesso Bed Mattress, 36x 80x6 Alesso Bed Mattress, 42x 80x6 Alesso Bed Mattress, 36x 84x6 Alesso Bed Mattress, 42x 84x6 Alesso Folding Assist Bar Alesso Bed Folding Assist Bar, Set of 2 Alesso Bed Folding Assist Bar

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2024-07-23
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2024-07-23
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2024-09-04

Official Correspondent

No official correspondent registered.

US Agent Details

David Carlson Business: Kwalu LLC Email: dcarlson@kwalu.com Phone: (678) 6905611

Related Public Records

Same Entity

Kwalu

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

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 3021907521. Last updated year: 2026. Please use registration number 3021907521 when referencing this establishment in official correspondence.