Juzo SoftCompress

SoftCompress Liner, Lower Leg , UNI

Registry build 21.09.26
2manufacturers in China registered for this device type
14catalogue 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 Juzo SoftCompress
Listed by Julius Zorn, Inc., United States
FDA product code MDR
Device type Binder, Medical, Therapeutic
Device class Class 1
Regulation 21 CFR 880.5160
Establishment Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-09-08
Record revised 2024-12-11 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Over the counter Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Juzo SoftCompress
Catalogue number Size Status
6838TH A In distribution
6822ACG 2 In distribution
6822ACG 4 In distribution
6838TH C In distribution
6823ACG UNI In distribution
6822ACG 1 In distribution
6838TH D In distribution
6822ACG 5 In distribution
6831AD UNI In distribution
6822ACG 6 In distribution
6838TH B In distribution
6838TH F In distribution
6822ACG 3 In distribution
6838TH E 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
CompreFLEX Sigvaris, Inc. 82
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

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