Jelco
10 catalogue numbers from HC11, listed by ICU Medical, Inc, United States, under Splint, Extremity, Noninflatable, External, Sterile. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
10catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Changzhou Meiguan Care Products Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 32 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Zhejiang Rehan Medical Manufacturing Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 20 |
| Hangzhou GspMed Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Anertai Industrial Limited | Dongguan | Guangdong | Exporter | 12 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | FYH |
| Device type | Splint, Extremity, Noninflatable, External, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 878.3910 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-26 |
| Record revised | 2026-02-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 20, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HC11 | In distribution | |
| HC12 | In distribution | |
| HC04 | In distribution | |
| HC08 | In distribution | |
| HC10 | In distribution | |
| FC00 | In distribution | |
| LS08 | In distribution | |
| EC06 | In distribution | |
| LS11 | In distribution | |
| LS12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Plastalume | Brownmed | 25 |
| Nice Stretch | Brownmed | 19 |
| SC | Allied Medical LLC | 9 |
| Dale Bendable Armboard | Dale Medical Products, Inc. | 8 |
| Inro Surgical Nail | Inro Medical Designs, Inc. | 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.