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.
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.
| 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
| 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
| 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 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
| 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.