Timm Medical
32 catalogue numbers from Esteem Cylinder with Insert, listed by POS-T-VAC, LLC, United States, under Device, External Penile Rigidity. 10 manufacturers in China are registered for this product code.
10manufacturers in China registered for this device type
32catalogue numbers in this listing
11510(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 | POS-T-VAC, LLC, United States |
|---|---|
| FDA product code | LKY |
| Device type | Device, External Penile Rigidity |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5020 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Esteem Cylinder with Insert | In distribution | |
| Small Insert | In distribution | |
| Large High Tension Ring (B) | In distribution | |
| Standard Beige Twin Pack | In distribution | |
| Large Standard Tension Ring (A) | In distribution | |
| Medium Max Elasticity Ring Grey | In distribution | |
| High Pink Twin Pack | In distribution | |
| Max II Cylinder | In distribution | |
| Esteem Manual Pump Head | In distribution | |
| Ring Loader Timm Line | In distribution | |
| EZ Ring #7 | In distribution | |
| UK Max Elasticity Grey Twin Pack | In distribution | |
| Large Max Elasticity Ring Grey ‘B’ | In distribution | |
| Large High Tension Ring (C) | In distribution | |
| Inverse TPRED Set Classic | In distribution | |
| Max I Cylinder | In distribution | |
| Max III Cylinder | In distribution | |
| EZ Ring #4 | In distribution | |
| Comfort Disposable Ring | In distribution | |
| Conduit Tubing 18″ | In distribution | |
| Reverse Coupler | In distribution | |
| Medium Standard Tension Ring (C) | In distribution | |
| Gasket Double Seal Ring | In distribution | |
| Medium High Tension Ring (D) | In distribution | |
| Venoseal | In distribution | |
| Esteem Battery Pump Head | In distribution | |
| Large Insert | In distribution | |
| EZ Ring #5 | In distribution | |
| Bio-Exsert | In distribution | |
| Scaled Sylinder | In distribution | |
| EZ Ring #6 | In distribution | |
| Cushion 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 |
| 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 |
| Rapport | Owen Mumford USA, Inc. | 7 |
Showing 12 of 106. All products under Device, External Penile Rigidity
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K020258 | 2002-04-04 |
| K020154 | 2002-04-04 |
| K012670 | 2001-11-09 |
| K012672 | 2001-11-09 |
| K983246 | 1998-11-02 |
| K983245 | 1998-11-02 |
| K981180 | 1998-08-28 |
| K981011 | 1998-08-28 |
| K960828 | 1996-03-08 |
| K960342 | 1996-03-01 |
| K941087 | 1994-07-25 |
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.