Aquaplast RT™

Aquaplast RT 30cm x 45cm (12" x 18") solid with bonded Groin Lock (pre-punched)

Registry build 21.09.26
8manufacturers in China registered for this device type
569catalogue numbers in this listing
6510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (2), Jiangsu (2), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IYE
Manufacturer City Province Registered as Device types
Guangzhou Tian Hong Medical Technology Co., Ltd. Guangzhou Guangdong Contract manufacturer 4
Klarity Medical & Equipment (GZ) Co., Ltd. Guangzhou Guangdong Contract manufacturer 3
Elekta Beijing Medical Systems Co., Ltd. Beijing Beijing Contract manufacturer 1
Manteia Technologies Co., Ltd. Xiamen Fujian Manufacturer 3
OUR United Corporation Xian Shaanxi Contract manufacturer 2
Suzhou Linatech Medical Science AND Technology Co., Ltd. Suzhou Jiangsu Manufacturer 2
Varian Medical Systems China Co., Ltd. Beijing Beijing Manufacturer 2
Jiangsu Rayer Medical Technology Co., Ltd. Wuxi Jiangsu Manufacturer 1

Record

Regulatory record for Aquaplast RT™
Listed by Qfix, United States
FDA product code IYE
Device type Accelerator, Linear, Medical
Device class Class 2
Regulation 21 CFR 892.5050
Record published 2016-12-22
Record revised 2026-02-16 (version 7)

Specifications

Specifications
MRI safety MR Safe
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Sizes Depth 1.6 to 4.8 mm; width 10 to 45 in; length 9 to 43 in; width 6 to 60 cm; length 5 to 45 cm
Distribution end date 2026-03-10
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Aquaplast RT™
Catalogue number Size Per pack Status
RT-1821P Depth 3.2 mm 10 In distribution
RT-1892 Width 24 in 5 In distribution
RT-1788P Depth 2.4 mm 5 In distribution
RT-1889ESD Depth 3.2 mm 10 In distribution
RT-1782PR4 Depth 2.4 mm 10 In distribution
RT-1892ESD Depth 3.2 mm 10 In distribution
RT-1782ORF3 Depth 2.4 mm 10 In distribution
RT-1882P18A Length 45 cm 5 In distribution
RT-1889ESDL Depth 3.2 mm 10 In distribution
RT-1889SX Depth 3.2 mm 5 In distribution
RT-1782PR3 Depth 2.4 mm 10 In distribution
RT-1889YSR Depth 3.2 mm 5 In distribution
RT-1913-3 Width 30 cm 5 In distribution
RT-1883P Width 18 in 5 In distribution
RT-1882ORF3 Depth 3.2 mm 5 In distribution
RT-1783P3 Depth 2.4 mm 5 In distribution
RT-1889S-S3 Depth 3.2 mm 5 In distribution
RT-1779SD Depth 2.4 mm 10 In distribution
RT-1989SO Depth 4.8 mm 4 In distribution
RT-1781P Length 9 in 5 In distribution
RT-1882BOS-DS Depth 3.2 mm 10 In distribution
RT-1969 Depth 4.8 mm 4 In distribution
RT-1889YSDR Depth 3.2 mm 10 In distribution
RT-1779L Depth 2.4 mm 5 In distribution
RT-1913-4 Width 30 cm 5 In distribution
RT-1889XO Depth 3.2 mm 5 In distribution
RT-1722P24 Depth 2.4 mm 5 In distribution
RT-1782ESD Depth 2.4 mm 10 In distribution
RT-1889S Depth 3.2 mm 5 In distribution
RT-1878BOS-D2L Width 38 cm 10 In distribution
RT-1779SDL Depth 2.4 mm 10 In distribution
RT-1882BOS-DVS Width 26 cm 10 In distribution
RT-1779X Depth 2.4 mm 5 In distribution
RT-1889L Depth 3.2 mm 5 In distribution
RT-1882BOS-D Depth 3.2 mm 10 In distribution
RT-1931-4 Depth 4.8 mm 5 In distribution
RT-1878BOS-D2LVS Width 26 cm 10 In distribution
RT-1779SO Depth 2.4 mm 5 In distribution
RT-1922 Length 45 cm 5 In distribution
RT-1889SD-S3 Depth 3.2 mm 10 In distribution
RT-1778PR5D Depth 2.4 mm 10 In distribution
RT-1782ORF4 Depth 2.4 mm 10 In distribution
RT-1823P12A Width 18 in 5 In distribution
RT-1889SDL Depth 3.2 mm 10 In distribution
RT-1779S Depth 2.4 mm 5 In distribution
RT-1882P Depth 3.2 mm 5 In distribution
RT-1989S Depth 4.8 mm 4 In distribution
RT-1778 Width 24 in 5 In distribution
RT-1779O Depth 2.4 mm 5 In distribution
RT-1889SO Depth 3.2 mm 5 In distribution
RT-1782PR5D Depth 2.4 mm 10 In distribution
RT-1889YS Depth 3.2 mm 5 In distribution
RT-1883P12A Length 30 cm 5 In distribution
RT-1889SXO Depth 3.2 mm 5 In distribution
RT-1778PR2DC Depth 2.4 mm 4 In distribution
RT-1782ORF5 Depth 2.4 mm 10 In distribution
RT-1889S-S3O Depth 3.2 mm 5 In distribution
RT-1889SLO Depth 3.2 mm 5 In distribution
RT-1889SX-S3O Depth 3.2 mm 5 In distribution
RT-1892YSDR Depth 3.2 mm 10 In distribution
RT-1878BOS-E2LS Depth 3.2 mm 10 In distribution
RT-1889 Depth 3.2 mm 5 In distribution
RT-1778ORF5 Depth 2.4 mm 10 In distribution
RT-1848 Depth 3.2 mm 5 In distribution
RT-1882BOS-E Width 48 cm 10 In distribution
RT-1782 Width 24 in 5 In distribution
RT-1892SD Depth 3.2 mm 10 In distribution
RT-1889X Depth 3.2 mm 5 In distribution
RT-1779ESD Depth 2.4 mm 10 In distribution
RT-1822 Width 24 in 5 In distribution
RT-1778PR3 Depth 2.4 mm 10 In distribution
RT-1910-4 Depth 4.8 mm 5 In distribution
RT-1779SL Depth 2.4 mm 5 In distribution
RT-1913-2 Width 30 cm 5 In distribution
RT-1878BOS-E2L Depth 3.2 mm 10 In distribution
RT-1782PR5 Depth 2.4 mm 10 In distribution
RT-1878BOS-D2LS Depth 3.2 mm 10 In distribution
RT-1882ORFPLV4 Depth 3.2 mm 10 In distribution
RT-1782BOS-DXS Depth 2.4 mm 10 In distribution
RT-1778PR5 Depth 2.4 mm 10 In distribution
RT-1782SD Depth 2.4 mm 10 In distribution
RT-1889SL Depth 3.2 mm 5 In distribution
RT-1822P18A Width 60 cm 5 In distribution
RT-1778PR2 Depth 2.4 mm 10 In distribution
RT-1882BOS-ES Width 43 cm 10 In distribution
RT-1779 Depth 2.4 mm 5 In distribution
RT-1889SD Depth 3.2 mm 10 In distribution
RT-1778ORF4 Depth 2.4 mm 10 In distribution
RT-1722 Length 18 in 5 In distribution
RT-1889O Depth 3.2 mm 5 In distribution
RT-1779SX Depth 2.4 mm 5 In distribution
RT-1778ORF3 Depth 2.4 mm 10 In distribution
RT-1782PR3D Depth 2.4 mm 10 In distribution
RT-1778PR3D Depth 2.4 mm 10 In distribution
RT-1782ORF3 Depth 2.4 mm 5 Withdrawn
RT-1782ORF3 Depth 2.4 mm Withdrawn
RT-1882BOS-DS Depth 3.2 mm Withdrawn
RT-1882BOS-D Width 38 cm 10 Withdrawn
RT-1848 Depth 3.2 mm Withdrawn
RT-1778PR4D Depth 2.4 mm 5 Withdrawn
RT-1882ORFPLV4 Depth 3.2 mm Withdrawn
RT-1889S-S3 Depth 3.2 mm Withdrawn
RT-1889X Depth 3.2 mm 5 Withdrawn
RT-1889SL-S3 Depth 3.2 mm 5 Withdrawn
RT-1896 Depth 3.2 mm Withdrawn
RT-1778PR3 Depth 2.4 mm 10 Withdrawn
RT-1882BOS-ES Width 43 cm Withdrawn
RT-1779SDL Depth 2.4 mm 10 Withdrawn
RT-1782ORF4 Depth 2.4 mm Withdrawn
RT-1778ORF5 Depth 2.4 mm Withdrawn
RT-1778 Length 18 in 5 Withdrawn
RT-1800S Depth 3.2 mm 5 Withdrawn
RT-1782S Depth 2.4 mm Withdrawn
RT-1889ESD Depth 3.2 mm Withdrawn
RT-1779L Depth 2.4 mm Withdrawn
RT-1930-4 Depth 4.8 mm Withdrawn
RT-1778 Width 24 in Withdrawn
RT-1779ESDL Depth 2.4 mm Withdrawn
RT-1878BOS-E2LS Depth 3.2 mm Withdrawn
RT-1783P3 Length 12 in 5 Withdrawn
RT-1889SX Depth 3.2 mm Withdrawn
RT-1892 Length 18 in 5 Withdrawn
RT-1882P Depth 3.2 mm 5 Withdrawn
RT-1782PR3 Depth 2.4 mm Withdrawn
RT-1930-4 Length 43 in 5 Withdrawn
RT-1889SD-S3 Depth 3.2 mm 10 Withdrawn
RT-1878BOS-D2L Width 38 cm Withdrawn
RT-1824 Depth 3.2 mm 5 Withdrawn
RT-1889O Depth 3.2 mm 5 Withdrawn
RT-1788P Depth 2.4 mm 5 Withdrawn
RT-1889SX-S3O Depth 3.2 mm Withdrawn
RT-1783P3 Depth 2.4 mm Withdrawn
RT-1989L Depth 4.8 mm 4 Withdrawn
RT-1782S Depth 2.4 mm 10 Withdrawn
RT-1883P12A Length 30 cm Withdrawn
RT-1882BOS-ES Depth 3.2 mm 10 Withdrawn
RT-1889S Depth 3.2 mm Withdrawn
RT-1679SX Depth 1.6 mm 5 Withdrawn
RT-1652LS Width 24 in 5 Withdrawn
RT-1892YSDR Depth 3.2 mm Withdrawn
RT-1882BOS-E Width 48 cm Withdrawn
RT-1782ORF3 Depth 2.4 mm Withdrawn
RT-1781P Depth 2.4 mm 5 Withdrawn
RT-1889XO Depth 3.2 mm Withdrawn
RT-1883P3 Length 12 in Withdrawn
RT-1892SD Depth 3.2 mm 10 Withdrawn
RT-1913-4 Width 30 cm Withdrawn
RT-1989L Depth 4.8 mm Withdrawn
RT-1910-4 Depth 4.8 mm Withdrawn
RT-1778PR4 Depth 2.4 mm Withdrawn
RT-1782PR5 Depth 2.4 mm Withdrawn
RT-1922 Width 60 cm 5 Withdrawn
RT-1783P Length 12 in 5 Withdrawn
RT-1878BOS-E2L Depth 3.2 mm Withdrawn
RT-1922 Length 45 cm Withdrawn
RT-1989 Depth 4.8 mm Withdrawn
RT-1722 Length 18 in 5 Withdrawn
RT-1779L Depth 2.4 mm 5 Withdrawn
RT-1889ESD Depth 3.2 mm 10 Withdrawn
RT-1882BOS-DVS Width 26 cm Withdrawn
RT-1597D Width 28 cm 5 Withdrawn
RT-1889SLO Depth 3.2 mm Withdrawn
RT-1800S Depth 3.2 mm Withdrawn
RT-1778PR5D Depth 2.4 mm 5 Withdrawn
RT-1882P18A Length 45 cm Withdrawn
RT-1782PR5D Depth 2.4 mm 5 Withdrawn
RT-1878BOS-E2LS Depth 3.2 mm Withdrawn
RT-1782ORF4 Depth 2.4 mm Withdrawn
RT-1779SDL Depth 2.4 mm Withdrawn
RT-1910-4 Depth 4.8 mm 5 Withdrawn
RT-1823P12A Width 18 in 5 Withdrawn
RT-1892SD Depth 3.2 mm Withdrawn
RT-1682SD Depth 1.6 mm Withdrawn
RT-1779SDS3 Depth 2.4 mm Withdrawn
RT-1782PR3D Depth 2.4 mm 10 Withdrawn
RT-1779R Depth 2.4 mm 5 Withdrawn
RT-1679SX Depth 1.6 mm Withdrawn
RT-1908-4 Length 7 cm Withdrawn
RT-1782ORF4 Depth 2.4 mm 10 Withdrawn
RT-1804 Width 36 in Withdrawn
RT-1821P Depth 3.2 mm Withdrawn
RT-1779SO Depth 2.4 mm Withdrawn
RT-1779S-S3 Depth 2.4 mm Withdrawn
RT-1779R Depth 2.4 mm Withdrawn
RT-1782BOS-DXS Depth 2.4 mm 10 Withdrawn
RT-1892ESD Depth 3.2 mm Withdrawn
RT-1878BOS-D2LVS Width 26 cm Withdrawn
RT-1882ORFPLV4 Depth 3.2 mm 10 Withdrawn
RT-1779 Depth 2.4 mm Withdrawn
RT-1597B Width 22 cm 5 Withdrawn
RT-1889X Depth 3.2 mm Withdrawn
RT-1778PR3 Depth 2.4 mm Withdrawn
RT-1999 Depth 4.8 mm 5 Withdrawn
RT-1889SD Depth 3.2 mm Withdrawn
RT-1889SO Depth 3.2 mm Withdrawn
RT-1779ESDX Depth 2.4 mm Withdrawn
RT-1782PR3D Depth 2.4 mm 5 Withdrawn
RT-1779S-S3F Depth 2.4 mm Withdrawn
RT-1779SDX Depth 2.4 mm Withdrawn
RT-1889SDX Depth 3.2 mm 10 Withdrawn
RT-1778PR4 Depth 2.4 mm 10 Withdrawn
RT-1622 Length 18 in Withdrawn
RT-1892SD Depth 3.2 mm Withdrawn
RT-1721P Depth 2.4 mm Withdrawn
RT-1779 Depth 2.4 mm 5 Withdrawn
RT-1778PR5D Depth 2.4 mm Withdrawn
RT-1778PR4D Depth 2.4 mm Withdrawn
RT-1779SO Depth 2.4 mm Withdrawn
RT-1778PR2 Depth 2.4 mm Withdrawn
RT-1889YSR Depth 3.2 mm 5 Withdrawn
RT-1889ESDX Depth 3.2 mm Withdrawn
RT-1889SL Depth 3.2 mm Withdrawn
RT-1778PR4 Depth 2.4 mm Withdrawn
RT-1892ESD Depth 3.2 mm Withdrawn
RT-1889SX-S3 Depth 3.2 mm 5 Withdrawn
RT-1778PR5 Depth 2.4 mm Withdrawn
RT-1889ESDX Depth 3.2 mm Withdrawn
RT-1889S Depth 3.2 mm 5 Withdrawn
RT-1779S-S3F Depth 2.4 mm 5 Withdrawn
RT-1882S Depth 3.2 mm 10 Withdrawn
RT-1878S Depth 3.2 mm 10 Withdrawn
RT-1779SXO Depth 2.4 mm 5 Withdrawn
RT-1931-4 Length 30 in 5 Withdrawn
RT-1822 Length 18 in 5 Withdrawn
RT-1992 Depth 4.8 mm 5 Withdrawn
RT-1889O Depth 3.2 mm Withdrawn
RT-1779SDX Depth 2.4 mm Withdrawn
RT-1913-2 Depth 2.4 mm 5 Withdrawn
RT-1778ORF3 Depth 2.4 mm 10 Withdrawn
RT-1889SO Depth 3.2 mm Withdrawn
RT-1779SDS3 Depth 2.4 mm Withdrawn
RT-1889SLO Depth 3.2 mm Withdrawn
RT-1679SL Depth 1.6 mm 5 Withdrawn
RT-1679 Depth 1.6 mm 5 Withdrawn
RT-1652LS Length 18 in Withdrawn
RT-1682 Width 24 in 5 Withdrawn
RT-1779O Depth 2.4 mm Withdrawn
RT-1778PR2 Depth 2.4 mm 10 Withdrawn
RT-1782ORF5 Depth 2.4 mm 5 Withdrawn
RT-1782ORF3 Depth 2.4 mm 10 Withdrawn
RT-1788P Depth 2.4 mm Withdrawn
RT-1889SLO Depth 3.2 mm 5 Withdrawn
RT-1889SX-S3 Depth 3.2 mm Withdrawn
RT-1889SL-S3 Depth 3.2 mm 5 Withdrawn
RT-1782SD Depth 2.4 mm Withdrawn
RT-1882BOS-DVS Width 26 cm 10 Withdrawn
RT-1778S Width 18 in 5 Withdrawn
RT-1989SO Depth 4.8 mm Withdrawn
RT-1597C Depth 2.4 mm 5 Withdrawn
RT-1778PR4D Depth 2.4 mm 10 Withdrawn

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Klarity Medical Klarity Medical Products, LLC 891
Orfit Industries Orfit Industries NV 680
Fibreplast® Qfix 271
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Vac-Lok™ Cushion Medtec LLC 100
Visicoil IZI Medical Products LLC 86
BodyFIX 3C-Medical Intelligence GmbH 84
AlignRT Plus Vision RT Limited 72
Fibreplast® Assure™ Open View Qfix 72
Accelerator, Linear, Medical PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH 71
Thermoplastic Mask IZI Medical Products LLC 58
Gold Anchor Naslund Medical AB 58

Showing 12 of 1,611. All products under Accelerator, Linear, Medical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K230312 2023-03-31
K193243 2020-02-28
K182189 2018-10-04
K171133 2017-07-11
K160627 2016-06-14
K152321 2015-12-04

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