Signacreme
Signacreme Electrode Creme 1/2 GAL Bottle.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls on this code
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 | Parker Laboratories, Inc., United States |
|---|---|
| FDA product code | GYB |
| Device type | Media, Electroconductive |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1275 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K782055 |
| Record published | 2017-07-05 |
| Record revised | 2018-10-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 4, box, box of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ELECTRODE CREAM | In distribution | ||
| ELECTRODE CREAM | 12 | 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 |
|---|---|
| K852956 | 1985-08-09 |
| K791013 | 1979-09-17 |
| K782055 | 1979-03-21 |
| K780973 | 1978-07-27 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-03-22 | Class II | Process change control | Product demonstrates low viscosity. | 217 cases (1,085 Inner Boxes; 10,850 Eaches) |
| 2024-01-22 | Class II | Under Investigation by firm | Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60. | 44 cases (6,336 units) (39 cases US, 5 cases OUS) |
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.