Excel Plus Comply Quilted PAD

Excel Plus Comply Quilted Pad, 10.5 oz. vinyl Laminate, 30x36, Mock Safety Stitch Construction RM (98 8002) USE: 61064100

Registry build 21.09.26
89manufacturers in China registered for this device type
12catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (23), Jiangsu (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FMW
Manufacturer City Province Registered as Device types
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Jiangsu Keling Medical Appliances Co., Ltd. Yangzhou Jiangsu Contract manufacturer 23
Jiangyin Huashi Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 21
Dongguan China Effort Healthcare Products Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Changzhou Care-DE Sanitary Material Co., Ltd. Changzhou Jiangsu Contract manufacturer 10
Hubei Haixin Protective Products Group Co., Ltd. Songzi Hubei Contract manufacturer 10
Shenzhen Lantise Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10
Changzhou Hongtai Paper Film Co., Ltd. Changzhou Jiangsu Contract manufacturer 9
Suzhou Baili Medical Supplies Co., Ltd. Suzhou Jiangsu Contract manufacturer 9
Jiangsu Hanfang Textile Technology Co., Ltd. Xuzhou Jiangsu Contract manufacturer 8
Jinhua Yueer ART Craft Co., Ltd. Jinhua Zhejiang Contract manufacturer 6
Haining Yikang Textile Co., Ltd. Haining Zhejiang Contract manufacturer 5

Showing 12 of 89. All 89 manufacturers in China registered for Cover, Mattress (Medical Purposes)

Record

Regulatory record for Excel Plus Comply Quilted PAD
Listed by Standard Textile Co., Inc., United States
FDA product code FMW
Device type Cover, Mattress (Medical Purposes)
Device class Class 1
Regulation 21 CFR 880.6190
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2018-01-29
Record revised 2024-09-24 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Distribution end date 2025-05-29

Catalogue Numbers

Catalogue numbers for Excel Plus Comply Quilted PAD
Catalogue number Size Per pack Status
61064M21 24 In distribution
61064EN0 24 In distribution
61064110 24 In distribution
61064100 24 In distribution
6106433Y 24 Withdrawn
610641G6 24 Withdrawn
61064310 24 Withdrawn
61064K05 24 Withdrawn
61064210 24 Withdrawn
61064P41 24 Withdrawn
61064EM4 24 Withdrawn
610642F1 24 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
C-Matt Casco Manufacturing Solutions, Inc. 171
Underpad Quilted Ibex Standard Textile Co., Inc. 68
Cmatt Casco Manufacturing Solutions, Inc. 43
Casco Casco Manufacturing Solutions, Inc. 35
Underpad Quilted Standard Textile Co., Inc. 29
SelectAir Moxi Enterprises, LLC 28
Alleset GRI Medical & Electronic Technology Co., Ltd. 20
Drivemedical Drive DeVilbiss Healthcare 19
Underpad Integrity Standard Textile Co., Inc. 18
CT Gantry Cover Pearl Inc. 16
ProtectYou2 Moxi Enterprises, LLC 13
Sures Vive Health LLC 12

Showing 12 of 244. All products under Cover, Mattress (Medical Purposes)

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