Drivemedical

Pressure PreventionGroup 1 Surfaces Product Description: APP Sys,Standard,Fixed Pressure,1/ea,RTL

Registry build 21.09.26
52manufacturers in China registered for this device type
22catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (18), Jiangsu (13), Fujian (10). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FNM
Manufacturer City Province Registered as Device types
Jiangsu Saikang Medical Equipment Co., Ltd. Zhangjiagang Jiangsu Contract manufacturer 34
Foshan Hongfeng Co., Ltd. Foshan Guangdong Contract manufacturer 24
Cofoe Medical Technology Co., Ltd. Changsha Hunan Contract manufacturer 22
Jiangyin Newrise Medical Equipment Co., Ltd. Jiangyin Jiangsu Contract manufacturer 10
Xiamen Senyang Co., Ltd. Xiamen Fujian Contract manufacturer 7
SHL Healthcare Ltd. Shenzhen Guangdong Contract manufacturer 5
Xiamen HOY Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 5
Apex Medical (Kunshan) Corp. Kunshan Jiangsu Contract manufacturer 4
Shenzhen Fitconn Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 4
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Dragon Medical Co., Ltd. Suzhou Jiangsu Contract manufacturer 48

Showing 12 of 52. All 52 manufacturers in China registered for Mattress, Air Flotation, Alternating Pressure

Record

Regulatory record for Drivemedical
Listed by Drive DeVilbiss Healthcare, United States
FDA product code FNM
Device type Mattress, Air Flotation, Alternating Pressure
Device class Class 2
Regulation 21 CFR 880.5550
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2016-07-01
Record revised 2024-09-19 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, serial number
Packaging Pack of 6, pack of 10
Distribution end date 2024-08-20

Catalogue Numbers

Catalogue numbers for Drivemedical
Catalogue number Size Status
14002E In distribution
14029M-MINI In distribution
BA9600-NP In distribution
BA9600-P-42 In distribution
BA9600-P-84 In distribution
14001EFD In distribution
BA9600-CUSTOM In distribution
14027-FBS In distribution
14530M-MINI In distribution
14026 In distribution
14001E In distribution
14003 In distribution
14003-EF In distribution
IH-LS900042 Withdrawn
BA9600-NPCM Withdrawn
IH-LS9000 Withdrawn
BA9600-PKG Withdrawn
IH-14530 Withdrawn
BA9600-NPMINI Withdrawn
14001ECAN Withdrawn
BA9600-P-42-PKG Withdrawn
IH-LS900048 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
PressureGuard Span-America Medical Systems, Inc. 328
Span-America Span-America Medical Systems, Inc. 286
Medline Medline Industries, Inc. 228
K-2oem ALT-Aire + KAP Medical 130
SenTech Tridien Medical 129
Mattress, Air Flotation, Alternating Pressure Carilex Medical, Inc. 118
K-2 Kare-Zone KAP Medical 107
K-4oem Aire-Float KAP Medical 90
K-1oem ALT-Aire KAP Medical 72
K-4 D³X KAP Medical 70
Sizewise Sizewise Rentals, L.L.C. 68
K-1 Derma-Kare KAP Medical 58

Showing 12 of 429. All products under Mattress, Air Flotation, Alternating Pressure

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