Xtra-Comfort
Water Pillow (V2)
114manufacturers in China registered for this device type
2catalogue 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.
| 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 | Vive Health LLC, United States |
|---|---|
| FDA product code | IQK |
| Device type | Orthosis, Cervical |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-02 |
| Record revised | 2023-09-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Packaging | Case of 9, case of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSH1065WHT | In distribution | |
| CSH1071WHT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 554 |
| Cervmax® | PMT Corp. | 191 |
| Breg | Breg, Inc. | 26 |
| 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 |
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.