Coulmed

Double Sided Foam Wedge Positioner..Standard Foam with Reusable Conductive Covering. Includes Velcro Strip along bottom center...Base Size: 18”W x 26”L x 4-1/2” to 6”H..Double Wedge Size:…

Registry build 21.09.26

Double Sided Foam Wedge Positioner..Standard Foam with Reusable Conductive Covering. Includes Velcro Strip along bottom center…Base Size: 18”W x 26”L x 4-1/2” to 6”H..Double Wedge Size: 17-7/16”L x 10-1/2”L

66manufacturers in China registered for this device type
135catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Zhejiang (16), Guangdong (11). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CCX
Manufacturer City Province Registered as Device types
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Suzhou Meccan Import and Export Corp. Suzhou Jiangsu Contract manufacturer 71
Apex (Guangzhou) Tools & Orthopedics Company Guangzhou Guangdong Contract manufacturer 62
Lingxian Dongsheng Textile Co., Ltd. Dezhou Shandong Contract manufacturer 23
Jinhua Ivy Home Textile Co., Limited Jinhua Zhejiang Contract manufacturer 18
Shenzhen Zhouyang Medical Care Product Co., Ltd. Shenzhen Guangdong Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17
Jiangsu Classic NEW-Type Medical Products Co., Ltd. Yancheng Jiangsu Contract manufacturer 13
Kunshan Jiehong Nonwoven Product Co., Ltd. Kunshan Jiangsu Contract manufacturer 12
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Anhui Ivymed Medical Products Co., Ltd. Xuancheng Anhui Contract manufacturer 10
Suzhou Baili Medical Supplies Co., Ltd. Suzhou Jiangsu Contract manufacturer 9

Showing 12 of 66. All 66 manufacturers in China registered for Support, Patient Position

Record

Regulatory record for Coulmed
Listed by Coulmed Products Group LLC, United States
FDA product code CCX
Device type Support, Patient Position
Device class Class 1
Regulation 21 CFR 868.6820
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2023-01-06
Record revised 2025-02-06 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied as a kit Yes
Packaging Pack of 2, case of 3, pack of 10

Catalogue Numbers

Catalogue numbers for Coulmed
Catalogue number Size Per pack Status
GP305 In distribution
GP618 In distribution
GP627-L In distribution
AP326-GPR In distribution
GP311 In distribution
GP407-SD In distribution
304-2 2 In distribution
FP-506-CC In distribution
GP651 In distribution
GP404 In distribution
BP2231R In distribution
185-1 2 In distribution
GP627 In distribution
GP400 In distribution
170-4 In distribution
GP406 In distribution
FP-170-9 In distribution
GP304 In distribution
303-3 2 In distribution
GP707 In distribution
AP324-GPR In distribution
FP-228-VCV In distribution
GP653 In distribution
GP162 In distribution
GP624 In distribution
GP407-SET In distribution
303-4 2 In distribution
GP314 In distribution
FP-401-CC 3 In distribution
FP-504-APC In distribution
FP-501-CC-WOV In distribution
GP401 In distribution
GP212 In distribution
GP214 In distribution
AC3900-BP In distribution
FP-165-5CC In distribution
185-4 2 In distribution
GP405-SET In distribution
GP621 In distribution
AC2201-5P In distribution
182-8 2 In distribution
FP-165-4CC In distribution
FP-2912-CC In distribution
GP110 In distribution
181-4 2 In distribution
GP402 In distribution
GP216-3FB In distribution
AC2201-3P In distribution
FP-503-CNS In distribution
GP502 In distribution
AC3800-BP-R In distribution
170-6 In distribution
GP500-WP In distribution
FP-508-CC In distribution
GP605 In distribution
FP-509-CC In distribution
GP213 In distribution
GP310 In distribution
GP309-5 In distribution
GP211 In distribution
304-4 2 In distribution
GP610 In distribution
FP-505-SC In distribution
AC03-P In distribution
GP307 In distribution
GP40304L In distribution
GP313 In distribution
GP602-ES In distribution
GP701 2 In distribution
GP612 In distribution
AC939 10 In distribution
GP315 In distribution
GP710 In distribution
FP-502-CC In distribution
GP601 In distribution
FP-510-CC In distribution
GP316 In distribution
GP622 In distribution
AC28-P In distribution
GP159-4 In distribution
FP-507-CC In distribution
GP617 In distribution
GP403 In distribution
GP216-1FB In distribution
AC11 In distribution
GP203 In distribution
GP303 In distribution
GP632 In distribution
GP600 In distribution
GP204 In distribution
AP226-GPR In distribution
GP404-XLT In distribution
GP500 In distribution
GP616 In distribution
GP709 2 In distribution
GP207-2 In distribution
182-5 2 In distribution
FP-501-CC In distribution
FP-CTP18 In distribution
GP301 In distribution
AC3800-BP-L In distribution
GP650 In distribution
FP-503-CC In distribution
FP-5102-709 In distribution
AC3300-BP In distribution
GP160 In distribution
GP652 In distribution
GP312 In distribution
GP602 In distribution
GP206 In distribution
GP620 In distribution
GP405 In distribution
GP501 2 In distribution
AC3800-BP In distribution
GP216-2FB In distribution
304-1 2 In distribution
GP405-SD In distribution
181-5 2 In distribution
GP209 In distribution
GP613 In distribution
GP214-T In distribution
FP-505-CC In distribution
GP201 In distribution
GP207 In distribution
AC3400-BP In distribution
GP611 In distribution
GP619 In distribution
GP615 In distribution
GP216 In distribution
GP407 In distribution
GP302 In distribution
GP623 In distribution
TP-8001-709 In distribution
GP725 In distribution
GP161 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 225
Soule Medical Soule Co., THE 212
Techno-Aide Techno-Aide, Inc. 108
BoneFoam Bone Foam Inc. 93
Halyard Owens & Minor Distribution, Inc. 80
Devon Cardinal Health 75
Domico Med-Device Domico Med-Device, LLC 69
Universal Lateral Positioner® Innovative Medical Products, Inc. 69
Lateral Patient Positioning System Alphatec Spine, Inc. 65
Cardinal Health Cardinal Health 200, LLC 64
Pediatric Patient Positioner Alphatec Spine, Inc. 55
Support, Patient Position David Scott Company. 51

Showing 12 of 1,485. All products under Support, Patient Position

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer