ManaMed

The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and…

Registry build 21.09.26

The ManaEZ Rom Elite adjustable knee brace allows the user to adjust the length of the brace for custom fitting. This product is ideal for knee ligament damage, knee surgeries, and instability of the knee. The ManaEZ Rom Elite is designed for post-operative fixation, allowing the doctor to lock the patient into extension and control range of motion as prescribed. ManaEZ ROM Elite is a quick fitting, universal, telescoping, and drop lock post op knee brace. The brace has a unique malleable bar system to conform to all shapes and sizes. -Telescoping and malleable hinge bars extendable from 16.5″ – 27″ (42cm – 68.5cm) -Hinge range of motion adjustment: Flexion (0° – 120°) and extension (0° – 90°) -Quick lock key offers ability to control and lock out the hinge motion to 0°, 15°, and 30° directly -Lightweight, latex free breathable material -Easy application, universal size with hook and buckle closure, design fits either leg

137manufacturers in China registered for this device type
46catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (35), Jiangsu (33), Zhejiang (18). 30 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ITQ
Manufacturer City Province Registered as Device types
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
Xiamen Ortocare Sports Health Co., Ltd. Xiamen Free Trade Zone Fujian Contract manufacturer 32
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Fortune Company Ltd. Huizhou Guangdong Contract manufacturer 23
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Beijing Jinwei Kangda Medical Instrument Ltd. Langfang Hebei Contract manufacturer 21
Hengshui Xukang Medical Appliances Co., Ltd. Hengshui Hebei Contract manufacturer 21
Wenzhou Zuoyou Medical Technoloyg Co., Ltd. Wenzhou Zhejiang Contract manufacturer 21
Foshan Huafukang Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 19
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Anhui Kangfu Industrial Foreign Trade Co., Ltd. Tianchang Anhui Contract manufacturer 18

Showing 12 of 137. All 137 manufacturers in China registered for Joint, Knee, External Brace

Record

Regulatory record for ManaMed
Listed by Manamed LLC, United States
FDA product code ITQ
Device type Joint, Knee, External Brace
Device class Class 1
Regulation 21 CFR 890.3475
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-06-23
Record revised 2026-01-12 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, manufacturing date
Distribution end date 2024-03-01

Catalogue Numbers

Catalogue numbers for ManaMed
Catalogue number Size Status
ManaEZ Hinged Knee Brace X-Small In distribution
Cabo Knee XX-Large Right In distribution
EZOA Right In distribution
ManaEZ Wrap 33 In distribution
Cabo Knee XX-Large Left In distribution
Cabo Knee Large Right In distribution
ManaEZ Hinged Knee Brace XX-Large In distribution
GOATR In distribution
ManaEZ Hinged Knee Brace XXX-Large In distribution
ManaEZ ROM Ice In distribution
Cabo Knee Large Left In distribution
Cabo Knee X-Large Right In distribution
EZOA Left In distribution
ManaEZ ROM Elite Short In distribution
Cabo Knee Small Left In distribution
ManaEZ Ice Wrap Knee 2 In distribution
ManaEZ Hinged Knee Brace Medium In distribution
Cabo Knee Small Right In distribution
Cabo Knee Medium Right In distribution
ManaEZ Hinged Knee Brace X-Large In distribution
GOATL In distribution
Cabo Knee X-Large Left In distribution
ManaEZ Hinged Ice In distribution
ManaEZ Ice Wrap Hip In distribution
ManaEZ Hinged Knee Brace Small In distribution
Cabo Knee Medium Left In distribution
ManaEZ ROM Elite In distribution
ManaEZ Hinged Knee Brace Large In distribution
ManaOA, STD, LFT, PB Withdrawn
ManaForce, ATC, RGT Withdrawn
ManaOA, STD, RGT Withdrawn
ManaOA+ HD, LFT Withdrawn
ManaForceOA, LFT Withdrawn
ManaOA STD, LFT Withdrawn
ManaOA, RGT, PB Withdrawn
ManaEZ Ice Wrap Hip 2 Withdrawn
ManaEZ Ice Wrap Knee Withdrawn
ManaOA HD, RGT, PB Withdrawn
ManaForce, RT, RGT Withdrawn
ManaOA HD, LFT Withdrawn
ManaForce, RT, LFT Withdrawn
ManaForce, ATC, LFT Withdrawn
ManaOA+, HD, RGT Withdrawn
ManaOA HD, LFT, PB Withdrawn
ManaForceOA, RGT Withdrawn
ManaOA, HD, RGT Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 987
Medi Medi Manufacturing Inc 413
Vive Vive Health LLC 122
Donjoy Performance DJO, LLC 107
CoreTech Vive Health LLC 105
NON Franchise DJO, LLC 61
Gripper Hinged Knee Medical Specialties, Inc. 46
Profit Pantymed S.A. 46
Copperfit Ideavillage Products Corp. 42
M-Brace Air Indaco SRL 42
Joint, Knee, External Brace Tetra Medical Supply Corp. 35
BMI Blake Manufacturing, Inc. 34

Showing 12 of 507. All products under Joint, Knee, External Brace

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