CoreTech

Large Standard Back Brace (Black)

Registry build 21.09.26
110manufacturers in China registered for this device type
17catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (35), Jiangsu (18), Zhejiang (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IQE
Manufacturer City Province Registered as Device types
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
Henan Huibo Medical Co., Ltd. Nanyang Henan Contract manufacturer 17
Shenzhen City U-Lucky Sporting Goods Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
Tops Medical Articles Industries Nantong Inc Qidong Jiangsu Contract manufacturer 17
Yangzhou Feiyali Sporting Goods Co., Ltd. Yangzhou Jiangsu Contract manufacturer 15
Dongguan Vincent Rehab Devices Company Limited Dongguan Guangdong Contract manufacturer 11
Zhejiang Steriger Sports Medicine Technology Co., Ltd. Yiwu Zhejiang Contract manufacturer 11
Fenglin Industry Co., Ltd. Dongguan Guangdong Contract manufacturer 10
Dongguan Suscong Healthcare Co., Ltd. Dongguan Guangdong Contract manufacturer 9

Showing 12 of 110. All 110 manufacturers in China registered for Orthosis, Lumbar

Record

Regulatory record for CoreTech
Listed by Vive Health LLC, United States
FDA product code IQE
Device type Orthosis, Lumbar
Device class Class 1
Regulation 21 CFR 890.3490
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2022-07-15
Record revised 2024-09-18 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Over the counter Yes
Label carries lot or batch number
Packaging Case of 10, case of 40, case of 20, case of 8, case of 45, case of 6
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for CoreTech
Catalogue number Size Status
SUP2073BLKL In distribution
SUP2026BLK In distribution
SUP3064BLK In distribution
SUP3065BLK In distribution
SUP2057BLK In distribution
SUP2057BLKL In distribution
SUP3093BLK In distribution
SUP2073BLK In distribution
SUP3060BLK In distribution
SUP2025BLK In distribution
SUP3107BLK In distribution
SUP3066BLK In distribution
SUP3114BLK In distribution
SUP3011BLK In distribution
SUP3016BLK In distribution
SUP3163BLK In distribution
SUP3056BLK In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Medi Medi Manufacturing Inc 118
Neotech Care Neotech Care Inc. 84
Curble Chair Ablue Co., Ltd. 42
Copperfit Ideavillage Products Corp. 34
Vive Vive Health LLC 30
Best Back Indaco SRL 28
M-Brace Air Indaco SRL 24
Breg Breg, Inc. 18
Push braces Nea International B.V. 12
Tairuibosi Tianjin Tairuibosi Medical Appliance Co., Ltd. 9
Boston Brace Boston Brace International, Incorporated 8
Guardian Supporter BM Korea Co., Ltd. 8

Showing 12 of 67. All products under Orthosis, Lumbar

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