Who else makes this device?

Name: Oxevision Sleep system
Brand: Oxevision Sleep system

Neurology › TherapeuticDevice, Sleep Assessment

Oxevision Sleep System

Sleep disorder interpretive software, professional-only

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 Oxevision Sleep system
Listed by	Oxehealth Ltd, United Kingdom
FDA product code	LEL
Device type	Device, Sleep Assessment
Device class	Class 2
Regulation	21 CFR 882.5050
Establishment	Manufacturer
510(k)	K233618
Record published	2025-01-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date

Catalogue Numbers

Catalogue numbers for Oxevision Sleep system
Catalogue number	Size	Status
2		In distribution

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
Braebon Ultima Body Position Sensor with 2.5 mm phone connector	Braebon Medical Corp.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K233618	2024-04-03

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.