Gelzone Wrap
Hypertrophic and Keloid Scar Management, Joint and Muscle Support/Compression
85manufacturers in China registered for this device type
10catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (14), Shanghai (13). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Winner Medical (Huanggang) Co., Ltd. | Huanggang | Hubei | Contract manufacturer | 9 |
| Smith & Nephew (Suzhou) Limited | Suzhou | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 85. All 85 manufacturers in China registered for Elastomer, Silicone, For Scar Management
Record
| Listed by | Implantech Associates, Inc., United States |
|---|---|
| FDA product code | MDA |
| Device type | Elastomer, Silicone, For Scar Management |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4025 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K013732 |
| Record published | 2021-04-30 |
| Record revised | 2024-02-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25cmx122cm (10 in x 48 in) | In distribution | |
| 15cm x122cm (6 in x 48 in) | In distribution | |
| 5 cm x 41 cm (2 in x16 in) | In distribution | |
| 10 cm x 30 cm (4 in x12 in) | In distribution | |
| 2.5 cm X 30 cm (1 in x12 in) | In distribution | |
| 16 cm x122 cm (6 in x48 in) | In distribution | |
| 25cm x122cm (10 in x48 in) | In distribution | |
| 5 cm x 30 cm (2 in x12 in) | In distribution | |
| 10 cm x 61 cm (4 in x 24 in) | In distribution | |
| 10cm x102 cm (4 in x 40 in) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EPI-Derm | Biodermis LLC | 77 |
| Scar AID | Biodermis LLC | 57 |
| NewGel+ Silicone Gel Sheeting | Newmedical Technology, Inc. | 28 |
| Silagen Silicone Gel Sheeting | Newmedical Technology, Inc. | 24 |
| Dermasof | Biodermis LLC | 20 |
| ScarMD | AIM Medical Inc | 14 |
| Scar Fx | Scar Heal | 14 |
| Cimeosil® Scar Management, Gel Sheet | Implantech Associates, Inc. | 13 |
| Therafoam | Biodermis LLC | 10 |
| NEW Beginnings® Gelshapes® | PMT Corp. | 9 |
| Invisiderm™ Scar Management, Gel Sheet | Implantech Associates, Inc. | 8 |
| EPI-Foam | Biodermis LLC | 8 |
Showing 12 of 137. All products under Elastomer, Silicone, For Scar Management
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K013732 | 2002-02-07 |
| K012419 | 2001-10-24 |
| K964846 | 1997-02-12 |
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.