TUFFease®
TUFFease® Foot Section with Perineal Cutout 20" x 20" x 1/2"
101manufacturers in China registered for this device type
43catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (31), Zhejiang (21), Jiangsu (19). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Shenzhen Zhouyang Medical Care Product Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Dongguan Shihui Living Products Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Premier Guard Zhongshan Limited | Zhongshan | Guangdong | Contract manufacturer | 10 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
Showing 12 of 101. All 101 manufacturers in China registered for Protector, Skin Pressure
Record
| Listed by | Innovative Medical Products, Inc., United States |
|---|---|
| FDA product code | FMP |
| Device type | Protector, Skin Pressure |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6450 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-11-27 |
| Record revised | 2023-12-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | manufacturing date |
| Distribution end date | 2024-04-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TE-MBP | In distribution | |
| TE-LXP | In distribution | |
| TE-617 | Withdrawn | |
| TE-602 | Withdrawn | |
| TE-LGP | Withdrawn | |
| TE-104-C | Withdrawn | |
| TE-0238-1 | Withdrawn | |
| TE-608 | Withdrawn | |
| TE-5303 | Withdrawn | |
| TE-0239 | Withdrawn | |
| TE-402 | Withdrawn | |
| TE-403 | Withdrawn | |
| TE-308 | Withdrawn | |
| TE-616 | Withdrawn | |
| TE-620 | Withdrawn | |
| TE-615 | Withdrawn | |
| TE-308-1 | Withdrawn | |
| TE-619 | Withdrawn | |
| TE-703 | Withdrawn | |
| TE-104-B | Withdrawn | |
| TE-624 | Withdrawn | |
| TE-105 | Withdrawn | |
| TE-104-A | Withdrawn | |
| TE-309 | Withdrawn | |
| TE-PSP | Withdrawn | |
| TE-WP | Withdrawn | |
| TE-605 | Withdrawn | |
| TE-ASIS | Withdrawn | |
| TE-618 | Withdrawn | |
| TE-202 | Withdrawn | |
| TE-502 | Withdrawn | |
| TE-ULP SET | Withdrawn | |
| TE-621 | Withdrawn | |
| TE-0239-1 | Withdrawn | |
| TE-ULPBP | Withdrawn | |
| TE-110 | Withdrawn | |
| TE-100 | Withdrawn | |
| TE-306 | Withdrawn | |
| TE-304 | Withdrawn | |
| TE-404 | Withdrawn | |
| TE-103 | Withdrawn | |
| TE-ULPLP | Withdrawn | |
| TE-201 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Action® | Action Products, Inc. | 485 |
| Primo | ASP Global, LLC | 147 |
| Allen | Hill-ROM, Inc. | 141 |
| Blue Diamond | David Scott Company. | 114 |
| DeRoyal | Deroyal Industries, Inc. | 85 |
| Primo/ASP Medical | ASP Global, LLC | 68 |
| Darco® Toe Cap | Darco (Europe) GmbH | 52 |
| Mölnlycke®Z-Flo™ Fluidized Positioner | Mölnlycke Health Care AB | 50 |
| Bioseal Inc. | Bioseal | 31 |
| Darco® PegContour™ Insole | Darco (Europe) GmbH | 26 |
| SpandaNette | Medi-Tech, Inc. | 23 |
| Dermacare | Ehob, Inc. | 23 |
Showing 12 of 783. All products under Protector, Skin 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.