Who else makes this device?

Name: Braebon Ultima Body Position Sensor with 2.5 mm phone connector
Brand: Braebon Ultima Body Position Sensor with 2.5 mm phone connector

Neurology › TherapeuticDevice, Sleep Assessment

Braebon Ultima Body Position Sensor With 2.5 Mm Phone Connector

Catalogue number 0534, listed by Braebon Medical Corp., Canada, under Device, Sleep Assessment. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LEL
Manufacturer	City	Province	Registered as	Device types
Shenzhen Fenda Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	1

Record

Regulatory record for Braebon Ultima Body Position Sensor with 2.5 mm phone connector
Listed by	Braebon Medical Corp., Canada
FDA product code	LEL
Device type	Device, Sleep Assessment
Device class	Class 2
Regulation	21 CFR 882.5050
Establishment	Specification developer, Repacker / relabeller, Manufacturer
510(k)	K981969
Record published	2016-09-22
Record revised	2024-07-15 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature 0 to 60 °C; Storage environment humidity 10 to 95 % RH
Distribution end date	2023-01-02

Catalogue Numbers

Catalogue numbers for Braebon Ultima Body Position Sensor with 2.5 mm phone connector
Catalogue number	Size	Status
0534		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Braebon Ultima Body Position Sensor	Braebon Medical Corp.	5
EmbraceMini	Empatica SRL	2
Braebon Ultima Body Position Sensor for Alice 5	Braebon Medical Corp.	2
MotionWatch	Camntech	2
PRO-Diary	Camntech	2
ActiGraph	ActiGraph L.L.C.	2
Neurovirtual	Neurovirtual USA, Inc.	1
Actiwave	Camntech	1
EasyNet	Cadwell Industries, Inc.	1
Oxevision Sleep system	Oxehealth Ltd	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K981969	1998-08-20

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.