Dr. Joel Kaplan
Metal Hand Pump System - Size Extra Large
10manufacturers in China registered for this device type
9catalogue 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 | DR Joel Kaplan Inc, United States |
|---|---|
| FDA product code | LKY |
| Device type | Device, External Penile Rigidity |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5020 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-04-14 |
| Record revised | 2025-04-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
| Sizes | Lumen/inner diameter 1.75 to 2.5 in; length 9 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0201-200 | Lumen/Inner Diameter 2.00 in | In distribution |
| 0302-250-W | Lumen/Inner Diameter 2.50 in | In distribution |
| 0201-250 | Lumen/Inner Diameter 2.50 in | In distribution |
| 0201-225 | Lumen/Inner Diameter 2.25 in | In distribution |
| 0302-225-W | Lumen/Inner Diameter 2.25 in | In distribution |
| 0302-175-W | Lumen/Inner Diameter 1.75 in | In distribution |
| 0302-200-W | Lumen/Inner Diameter 2.00 in | In distribution |
| 0904-001 | In distribution | |
| 0201-175 | Lumen/Inner Diameter 1.75 in | 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 |
| 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.