CompreFLEX

82 catalogue numbers from 14TC, listed by Sigvaris, Inc., United States, under Binder, Medical, Therapeutic. 2 manufacturers in China are registered for this product code.

Registry build 21.09.26
2manufacturers in China registered for this device type
82catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1).

Chinese manufacturers registered for FDA product code MDR
Manufacturer City Province Registered as Device types
Ningbo MPF Manufacturing Co., Ltd. Ningbo Zhejiang Contract manufacturer 35
Jiangsu Xinbei Electrical Appliances Co., Ltd. Wuxi Jiangsu Contract manufacturer 6

Record

Regulatory record for CompreFLEX
Listed by Sigvaris, Inc., United States
FDA product code MDR
Device type Binder, Medical, Therapeutic
Device class Class 1
Regulation 21 CFR 880.5160
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-01-24
Record revised 2024-12-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for CompreFLEX
Catalogue number Size Status
14TC Pressure,15-20 mmHg In distribution
MS02 Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
MS40 Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
24LS Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24KP Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
MS01 Pressure,15-20 mmHg In distribution
MS01 Pressure,15-20 mmHg In distribution
24LS Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24LC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24LC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
MS05 Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
MS03 Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
MS03 Pressure,15-20 mmHg In distribution
MS02 Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
MS05 Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
24LC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24KP Pressure,15-20 mmHg In distribution
MS03 Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24KP Pressure,15-20 mmHg In distribution
24LC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
MS04 Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
MS04 Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
24BK Pressure,15-20 mmHg In distribution
14TC Pressure,15-20 mmHg In distribution
MS04 Pressure,15-20 mmHg In distribution
MS05 Pressure,15-20 mmHg In distribution
24KP Pressure,15-20 mmHg In distribution
MS01 Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
MS02 Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution
24TC Pressure,15-20 mmHg In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medi Medi Manufacturing Inc 752
Solidea Calzificio Pinelli SRL 129
12 MedaFit Sigvaris, Inc. 126
Juzo Compression Wrap Julius Zorn, Inc. 117
11 CompreFit Sigvaris, Inc. 78
21 CoolFlex Sigvaris, Inc. 56
14 CompreFlex Arm Sigvaris, Inc. 44
Jobst Bella BSN Medical, Inc. 32
Bella Lite Glove BSN Medical, Inc. 32
Juzo Custom Compression Garments Julius Zorn, Inc. 29
14 CompreFlex Knee Sigvaris, Inc. 28
Jobst Relax BSN-Jobst Gmbh 24

Showing 12 of 355. All products under Binder, Medical, Therapeutic

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