Rapport – Vacuum Therapy Device
A non-sterile, reusable vacuum therapy impotence management system.
10manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
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 | Owen Mumford USA, Inc., United States |
|---|---|
| FDA product code | LKY |
| Device type | Device, External Penile Rigidity |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5020 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Record published | 2016-09-19 |
| Record revised | 2022-03-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Case of 5 |
| Sizes | Width 67 mm; length 220 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM 2000 | Width 67 mm | 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 |
| Gesiva Medical | Gesiva Medical LLC | 12 |
| Performance Plus | Blush Novelties | 12 |
| Dr. Joel Kaplan | DR Joel Kaplan Inc | 9 |
| Eddie | Giddy Holdings, Inc. | 8 |
| Vaxaid | DX Products Limited | 7 |
Showing 12 of 106. All products under Device, External Penile Rigidity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982275 | 1998-12-04 |
| K971443 | 1997-09-26 |
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.