Rapport
Rapport constriction rings - Size 9
10manufacturers in China registered for this device type
7catalogue numbers in this listing
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 |
| Premarket notification | Exempt |
| 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 |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature 5 to 40 °C |
| Packaging | Case |
| Sizes | Lumen/inner diameter 12 to 24 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SM 2203 | Lumen/Inner Diameter 12 mm | In distribution |
| SM 2209 | Lumen/Inner Diameter 24 mm | In distribution |
| SM 2205 | Lumen/Inner Diameter 17 mm | In distribution |
| SM 2009 | In distribution | |
| SM 2204 | Lumen/Inner Diameter 15.5 mm | In distribution |
| SM 2206 | Lumen/Inner Diameter 18.5 mm | In distribution |
| SM 2207 | Lumen/Inner Diameter 20 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.