Thera-Cream
Catalogue number TCT004, listed by Prizm Medical, Inc., United States, under Media, Electroconductive. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (1), Hubei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Top-rank Health Care Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Shenzhen Huayan E-Commerce Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Ever Strong Manufacturing Ltd | Dongguan | Guangdong | Contract manufacturer | 8 |
| Shenzhen Ulike Smart Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 6 |
| Praywise Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Wuhan Greentek PTY Ltd. | Wuhan | Hubei | Manufacturer | 3 |
Record
| Listed by | Prizm Medical, Inc., United States |
|---|---|
| FDA product code | GYB |
| Device type | Media, Electroconductive |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1275 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K032239 |
| Record published | 2020-04-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TCT004 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pharmaceutical Innovations | Pharmaceutical Innovations, Inc. | 34 |
| NuFACE | Nuface | 11 |
| Ten20 Conductive Paste | D. O. Weaver AND Company | 6 |
| Alpha-Stim | Parker Laboratories, Inc. | 4 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 4 |
| Ecogel 300 | Eco-Med Pharmaceutical Inc | 4 |
| Elefix | Nihon Kohden Corp. | 4 |
| Compumedics Quik-Gel | Compumedics Limited | 4 |
| Signaspray | Parker Laboratories, Inc. | 3 |
| Rochester | Rochester Electro Medical, Inc. | 3 |
| Covidien | Cardinal Health | 3 |
| Jmoon | Shenzhen Ulike Smart Electronics Co., Ltd. | 3 |
Showing 12 of 60. All products under Media, Electroconductive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K032239 | 2004-07-30 |
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.