Gesiva Medical
Contains one each Large Standard tension ring, Large High tension ring, Medium Standard tension ring, and Medium High tension ring.
10manufacturers in China registered for this device type
12catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Hong Kong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Armocon Technology Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 5 |
| Odeco Ltd. | Baoan District, Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shenzhen S-Hande Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou Zhongshu E-Commerce Co., Ltd. | Guangzhou | Guangdong | Exporter | 7 |
| Shenzhen Canwin Health Products Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Dongguan Dingfoo Plastic Products Co., Ltd. | Dongguan | Guangdong | Manufacturer | 5 |
| Junrong Jiaye (Dongguan) Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
| Dolanvy (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| D-PUB Electronic & Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 3 |
| Daka International Limited | Kowloon | Hong Kong | Exporter | 2 |
Record
| Listed by | Gesiva Medical LLC |
|---|---|
| FDA product code | LKY |
| Device type | Device, External Penile Rigidity |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5020 |
| Premarket notification | Exempt |
| Record published | 2017-10-13 |
| Record revised | 2018-04-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Packaging | Pack of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Vacuum Therapy System | In distribution | |
| Medium High Tension Ring | In distribution | |
| Carrying Case | In distribution | |
| Tension Ring Kit | In distribution | |
| Vacuum Pump Handle | In distribution | |
| Extra Large Clear Plastic Cylinder | In distribution | |
| Medium Standard Tension Ring | In distribution | |
| Large High Tension Ring | In distribution | |
| Large Standard Tension Ring | In distribution | |
| Tension Ring Loader | In distribution | |
| Clear Plastic Cylinder | In distribution | |
| Comfort Insert | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Performance | Blush Novelties | 53 |
| Bathmate | DX Products Limited | 41 |
| Encore | Encore, Inc. | 39 |
| Stay Hard | Blush Novelties | 37 |
| Timm Medical | POS-T-VAC, LLC | 32 |
| Pos-T-Vac | POS-T-VAC, LLC | 31 |
| Play With Me | Blush Novelties | 19 |
| Performance Plus | Blush Novelties | 12 |
| Dr. Joel Kaplan | DR Joel Kaplan Inc | 9 |
| Eddie | Giddy Holdings, Inc. | 8 |
| Vaxaid | DX Products Limited | 7 |
| Rapport | Owen Mumford USA, Inc. | 7 |
Showing 12 of 106. All products under Device, External Penile Rigidity
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.