Necklite
Necklite: 6 catalogue numbers listed by Flamor SRL, Italy, under Orthosis, Cervical-Thoracic, Rigid. 30 manufacturers in China are registered for this product code.
30manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (6), Fujian (6), Jiangsu (5). 3 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 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Beijing Jinwei Kangda Medical Instrument Ltd. | Langfang | Hebei | Contract manufacturer | 21 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Planet(Shanghai) International Co., Ltd. | Shanghai | Shanghai | Exporter | 93 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Planet (Anhui) International Co., Ltd. | Chuzhou | Anhui | Exporter | 80 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| AID United International Co., Limited | Shanghai | Shanghai | Specification developer | 65 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Dragon Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
Showing 12 of 30. All 30 manufacturers in China registered for Orthosis, Cervical-Thoracic, Rigid
Record
| Listed by | Flamor SRL, Italy |
|---|---|
| FDA product code | IQF |
| Device type | Orthosis, Cervical-Thoracic, Rigid |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3490 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| YLW | In distribution | |
| BLUE / SC | In distribution | |
| BLK / SC | In distribution | |
| BLUE | In distribution | |
| YLW / SC | In distribution | |
| BLK | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulife | Trulife, Inc. | 97 |
| VQ Orthocare | Vision Quest Industries, Inc. | 14 |
| DeRoyal | Deroyal Industries, Inc. | 4 |
| Miami J | Hygia Health Services, Inc. | 4 |
| Medi | Medi Manufacturing Inc | 4 |
| MedSource Cervical Collar | Medsource International, LLC | 2 |
| Ambu | Hygia Health Services, Inc. | 1 |
| Voss Cervical Laminectomy Harness | VM/Positioning, Inc. | 1 |
| Ampcare Restorative Posture Device | Ampcare, LLC | 1 |
| MedSource Extrication Device | Medsource International, LLC | 1 |
| MedSource Adjustable Collar | Medsource International, LLC | 1 |
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.