Who else makes this device?

Name: Envelo Arm Wrap X-Large Short Black
Brand: Envelo Arm Wrap X-Large Short Black

General Hospital › TherapeuticBinder, Medical, Therapeutic

Envelo Arm Wrap X-Large Short Black

Catalogue number 3104-ARS or 22097, 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

1catalogue number

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 Envelo Arm Wrap X-Large Short Black
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	2026-07-20

Specifications

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

Catalogue Numbers

Catalogue numbers for Envelo Arm Wrap X-Large Short Black
Catalogue number	Size	Status
3104-ARS or 22097	Pressure, 20-40 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
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.