Who else makes this device?

Name: L Head and Arm Cushions
Brand: L Head and Arm Cushions

Radiology › DiagnosticCradle, Patient, Radiologic

L Head and Arm Cushions

Catalogue number CO-03, listed by Octostop, Inc., Canada, under Cradle, Patient, Radiologic. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code KXH
Manufacturer	City	Province	Registered as	Device types
Guangdong Meicen Medical Equipment Co., Ltd.	Foshan	Guangdong	Manufacturer	7
Guangzhou Tian Hong Medical Technology Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	4

Record

Regulatory record for L Head and Arm Cushions
Listed by	Octostop, Inc., Canada
FDA product code	KXH
Device type	Cradle, Patient, Radiologic
Device class	Class 1
Regulation	21 CFR 892.1830
Establishment	Manufacturer
Premarket notification	Exempt
Record published	2017-11-16
Record revised	2019-05-23 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for L Head and Arm Cushions
Catalogue number	Size	Status
CO-03		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
pearltec	Pearl Inc.	27
ProFoam	Pearl Inc.	22
Moldcare RI II	Alcare Co., Ltd.	11
Moldcare	IZI Medical Products LLC	6
AccuBoost	Advanced Radiation Therapy, LLC	5
PearlFit	Pearl Inc.	3
ProBelt	Pearl Inc.	2
ProFoam Wedge 18x23x10 30°	Pearl Inc.	1
ProBelt 50 VH	Pearl Inc.	1
PearlFit Inlay Head	Pearl Inc.	1
ProBelt 350 Wrap	Pearl Inc.	1
Small U Head Cushions	Octostop, Inc.	1

Showing 12 of 137. All products under Cradle, Patient, Radiologic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K953246	1995-09-29
K930124	1994-02-09
K930357	1993-07-13

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.