Axiom

Axiom SP - Skin Protection and Positioning- CEL Fluid Cushion Assembly Incontinent Cover, 1515

Registry build 21.09.26
53manufacturers in China registered for this device type
1,366catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (21), Jiangsu (14), Zhejiang (9). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IMP
Manufacturer City Province Registered as Device types
Hangzhou Rollmed Co., Ltd. Hangzhou Zhejiang Contract manufacturer 127
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Kunshan Hi-Fortune Health Products Co., Ltd. Kunshan Jiangsu Contract manufacturer 32
Chiaphua Components (Jiangxi) Limited Yichun Jiangxi Contract manufacturer 23
Feishen Group Co., Ltd. Yongkang Zhejiang Contract manufacturer 22
Guangdong Marshell Electric Vehicle Co., Ltd. Zhaoqing Guangdong Contract manufacturer 22
Guangzhou Xinbo Electronic Co., Ltd. Guangzhou Guangdong Contract manufacturer 18
Zhenjiang Assure Medical Equipment Co Ltd Zhenjiang Jiangsu Contract manufacturer 18
Jiangsu Yuyue Medical Equipment & Supply Company Limited Jiangsu Jiangsu Contract manufacturer 17
Dongguan China Effort Healthcare Products Co., Ltd. Dongguan Guangdong Contract manufacturer 17
Shenzhen Lantise Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10

Showing 12 of 53. All 53 manufacturers in China registered for Cushion, Wheelchair

Record

Regulatory record for Axiom
Listed by Ki Mobility, United States
FDA product code IMP
Device type Cushion, Wheelchair
Device class Class 1
Regulation 21 CFR 890.3920
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-01-02
Record revised 2026-04-22 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number, manufacturing date
Sizes Length 14 to 22 in; width 14 to 20 in
Distribution end date 2024-11-21

Catalogue Numbers

Catalogue numbers for Axiom
Catalogue number Size Status
PXP 08 X 09, Black In distribution
ASP In distribution
Axiom P In distribution
PXSP 11 X 12, Purple In distribution
G In distribution
P In distribution
Axiom S In distribution
Axiom P In distribution
Axiom SP Fluid In distribution
PXSP 13 X 11, Blue In distribution
SPV In distribution
Axiom G In distribution
Axiom P In distribution
Axiom PXSP In distribution
PXP 11 X 10, Purple In distribution
PXP 08 X 10, Blue In distribution
Axiom S In distribution
Axiom S In distribution
PXSP 12 X 13, Purple In distribution
PXP 10 X 08, Black In distribution
PXSP 10 X 14, Black In distribution
PXSP 12 X 16, Black In distribution
Axiom PXSP In distribution
Axiom PXSP In distribution
PXP 12 X 13, Purple In distribution
SPF In distribution
Axiom G In distribution
P In distribution
SPV In distribution
PXP 15 X 13, Blue In distribution
ASP In distribution
Axiom SP Visco In distribution
Axiom PXSP In distribution
S In distribution
Axiom PXSP In distribution
ASP In distribution
PXSP 15 X 17, Blue In distribution
Axiom PXP In distribution
Axiom PXSP In distribution
Axiom PXSP In distribution
G In distribution
SPV In distribution
P In distribution
PXP 14 X 11, Black In distribution
ASP In distribution
PXSP 14 X 17, Black In distribution
Axiom SP Fluid In distribution
AS In distribution
PXSP 12 X 13, Black In distribution
PXP 08 X 10, Black In distribution
Axiom S In distribution
Axiom G In distribution
SPF In distribution
PXSP 13 X 10, Black In distribution
G In distribution
S In distribution
PXP 08 X 08, Purple In distribution
SPF In distribution
G In distribution
AS In distribution
Axiom SP Fluid In distribution
Axiom PXSP In distribution
ASP In distribution
S In distribution
Axiom PXSP In distribution
Axiom PXP In distribution
Axiom PXSP In distribution
ASP In distribution
Axiom P In distribution
P In distribution
AS In distribution
PXP 13 X 17, Blue In distribution
Axiom SP Fluid In distribution
Axiom SP Fluid In distribution
PXSP 10 X 14, Purple In distribution
Axiom PXP In distribution
Axiom S In distribution
SPF In distribution
AS In distribution
SPV In distribution
Axiom PXSP In distribution
PXP 14 X 11, Blue In distribution
Axiom G In distribution
Axiom P In distribution
PXSP 12 X 14, Black In distribution
Axiom PXSP In distribution
Axiom SP Fluid In distribution
PXP 11 X 14, Black In distribution
PXP 10 X 12, Purple In distribution
AS In distribution
Axiom PXSP In distribution
PXSP 10 X 10, Purple In distribution
G In distribution
Axiom SP Visco In distribution
Axiom PXP In distribution
SPV In distribution
Axiom G In distribution
Axiom PXP In distribution
SPF In distribution
PXP 13 X 12, Purple In distribution
Axiom PXSP In distribution
PXP 16 X 15, Black In distribution
One Length 17 in In distribution
Axiom PXP In distribution
ASP In distribution
Axiom SP Fluid In distribution
SPF In distribution
PXP 15 X 18, Black In distribution
PXSP 16 X 18, Blue In distribution
Axiom PXSP In distribution
PXSP 15 X 16, Black In distribution
SPV In distribution
Axiom SP Fluid In distribution
G In distribution
Axiom SP Visco In distribution
AS In distribution
Axiom P In distribution
PXSP 11 X 14, Blue In distribution
ASP In distribution
PXSP 13 X 15, Purple In distribution
P In distribution
Axiom PXP In distribution
Axiom PXSP In distribution
PXP 14 X 13, Blue In distribution
PXSP 11 X 09, Black In distribution
Axiom P In distribution
Axiom PXSP In distribution
G In distribution
PXSP 10 X 12, Blue In distribution
PXP 13 X 16, Blue In distribution
PXSP 16 X 17, Purple In distribution
G In distribution
Axiom G In distribution
PXSP 13 X 17, Purple In distribution
S In distribution
SPV In distribution
ASP In distribution
G In distribution
AS In distribution
Axiom SP Visco In distribution
PXSP 10 X 09, Purple In distribution
Axiom PXP In distribution
PXSP 12 X 13, Blue In distribution
One Length 22 in In distribution
SPV In distribution
Axiom PXSP In distribution
SPV In distribution
Axiom PXP In distribution
AS In distribution
G In distribution
Axiom S In distribution
ASP In distribution
Axiom PXSP In distribution
PXP 11 X 10, Blue In distribution
Axiom PXP In distribution
Axiom S In distribution
Axiom PXP In distribution
PXP 16 X 16, Black In distribution
Axiom PXSP In distribution
AS In distribution
ASP In distribution
S In distribution
Axiom PXSP In distribution
Axiom P In distribution
PXP 12 X 11, Blue In distribution
Axiom PXSP In distribution
SPF In distribution
Axiom P In distribution
S In distribution
Axiom PXP In distribution
PXP 11 X 14, Blue In distribution
PXSP 10 X 12, Black In distribution
S In distribution
AS In distribution
Axiom PXP In distribution
S In distribution
SPF In distribution
Axiom PXSP In distribution
Axiom SP Visco In distribution
Axiom SP Fluid In distribution
AS In distribution
Axiom S In distribution
AS In distribution
G In distribution
ASP In distribution
Axiom PXP In distribution
Axiom SP Fluid In distribution
Axiom S In distribution
Axiom PXP In distribution
PXP 08 X 08, Black In distribution
Axiom G In distribution
PXSP 08 X 08, Blue In distribution
Axiom PXP In distribution
PXSP 10 X 08, Blue In distribution
PXSP 10 X 11, Black In distribution
PXSP 11 X 11, Purple In distribution
PXSP 09 X 10, Black In distribution
SPV In distribution
PXP 13 X 13, Blue In distribution
SPF In distribution
SPV In distribution
Axiom PXSP In distribution
Axiom PXP In distribution
Axiom SP Fluid In distribution
PXSP 12 X 11, Purple In distribution
Axiom PXP In distribution
Axiom PXSP In distribution
Axiom SP Visco In distribution
PXP 15 X 13, Purple In distribution
Axiom P In distribution
Axiom PXSP In distribution
SPF In distribution
ASP In distribution
Axiom PXP In distribution
Axiom PXSP In distribution
S In distribution
PXP 09 X 10, Purple In distribution
SPF In distribution
PXSP 15 X 13, Blue In distribution
AS In distribution
ASP In distribution
PXP 13 X 11, Black In distribution
Axiom PXP In distribution
Axiom PXSP In distribution
Axiom SP Fluid In distribution
PXP 14 X 18, Black In distribution
Axiom SP Fluid In distribution
PXP 16 X 18, Purple In distribution
P In distribution
SPF In distribution
ASP In distribution
Axiom S In distribution
PXP 13 X 18, Black In distribution
PXP 13 X 17, Purple In distribution
Axiom S In distribution
SPV In distribution
Axiom G In distribution
G In distribution
PXSP 15 X 14, Purple In distribution
S In distribution
Axiom P In distribution
PXSP 11 X 14, Black In distribution
Axiom P In distribution
SPV In distribution
ASP In distribution
PXSP 12 X 15, Purple In distribution
Axiom P In distribution
Axiom SP Visco In distribution
Axiom G In distribution
Axiom P In distribution

Showing 250 of 300 catalogue numbers.

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Product Sold by Catalogue numbers
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Posture-Mate Immersus Health Company, LLC 53
Duo Standard Black cover Trulife, Inc. 45
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McKesson Mckesson Medical-Surgical Inc. 36
Supracor Stumulite Honeycomb Supracor, Inc. 33

Showing 12 of 1,026. All products under Cushion, Wheelchair

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