Breg

26 catalogue numbers from ASCEND PD2 PED COLLAR W/O REPL PADS, listed by Breg, Inc., United States, under Orthosis, Cervical. 114 manufacturers in China are registered for this product code.

Registry build 21.09.26
114manufacturers in China registered for this device type
26catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (30), Jiangsu (23), Zhejiang (17). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IQK
Manufacturer City Province Registered as Device types
Shanghai Leison Medical & Healthcare Products Co., Ltd. Shanghai Shanghai Contract manufacturer 32
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
Wellpower Sporting Goods Co., Ltd. Dong Guan Guangdong Contract manufacturer 18
Metacare Industrial Ltd Guangzhou Guangdong Contract manufacturer 17
IPE Plastic & Hardware Industy, Ltd Dongguan Guangdong Contract manufacturer 15
Yangzhou Feiyali Sporting Goods Co., Ltd. Yangzhou Jiangsu Contract manufacturer 15
Hengshui Tianjian Medical Supplies Co., Ltd. Shenzhou Hebei Contract manufacturer 14
Ambu Limited Xiang Yu F.T.Z., Xiamen Fujian Contract manufacturer 11
Jianxing Shoe Co., Ltd. Foshan Guangdong Contract manufacturer 11
Fenglin Industry Co., Ltd. Dongguan Guangdong Contract manufacturer 10

Showing 12 of 114. All 114 manufacturers in China registered for Orthosis, Cervical

Record

Regulatory record for Breg
Listed by Breg, Inc., United States
FDA product code IQK
Device type Orthosis, Cervical
Device class Class 1
Regulation 21 CFR 890.3490
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2023-09-11

Specifications

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

Catalogue Numbers

Catalogue numbers for Breg
Catalogue number Size Status
ASCEND PD2 PED COLLAR W/O REPL PADS In distribution
PINNACLE CERV TX 174 W/O REPL PADS In distribution
ASCEND CERVICAL COLLAR 172, SHORT In distribution
ASCEND CERV 172, TALL, W/O REPL PADS In distribution
PINNACLE CERV MP 180 W/O REPL PADS In distribution
ASCEND PD5 PEDIATRIC COLLAR In distribution
ASCEND PD1 PEDIATRIC COLLAR In distribution
ASCEND PD1 PED COLLAR W/O REPL PADS In distribution
PINNACLE CTO4 200 In distribution
ASCEND CERVICAL COLLAR 172, REGULAR In distribution
PINNACLE CERVICAL COLLAR 172 In distribution
PINNACLE CERVICAL COLLAR MP 180 In distribution
ASCEND PD3 PED COLLAR W/O REPL PADS In distribution
PINNACLE CERV 172 W/O REPL PADS In distribution
ASCEND CERV 172, SHRT, W/O REPL PADS In distribution
PINNACLE CTO 200 In distribution
PINNACLE CERVICAL COLLAR TX 174 In distribution
ASCEND CERVICAL COLLAR 172, X-TALL In distribution
ASCEND PD3 PEDIATRIC COLLAR In distribution
ASCEND CERV 172, REGULAR, W/O REPL PADS In distribution
ASCEND PD2 PEDIATRIC COLLAR In distribution
ASCEND PD5 PED COLLAR W/O REPL PADS In distribution
ASCEND PD4 PED COLLAR W/O REPL PADS In distribution
ASCEND PD4 PEDIATRIC COLLAR In distribution
ASCEND CERV 172, X-TALL, W/O REPL PADS In distribution
ASCEND CERVICAL COLLAR 172, TALL In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
DeRoyal Deroyal Industries, Inc. 554
Cervmax® PMT Corp. 191
Orthosis, Cervical Tetra Medical Supply Corp. 21
Wellbrace Pantymed S.A. 18
Two Piece Collar w/Trach Bird & Cronin, LLC 15
Cervical Collar Dynarex Corp. 14
Vive Vive Health LLC 14
Spencer Spencer Italia SRL 13
Perfit Collar™ Ambu A/S 12
Push braces Nea International B.V. 8
DR-HOS Guangzhou Xinbo Electronic Co., Ltd. 5
Restcloud Chengdu Si Hai Mu Ze Technology Co., Ltd. 5

Showing 12 of 107. All products under Orthosis, Cervical

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