Integra®
The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe for use in the surgical treatment of high and low anorectal malformation. The probe has a 260 cm…
The non sterile Peña Muscle Stimulator Bipolar Probe (PS2P) is a 17 cm long reusable probe for use in the surgical treatment of high and low anorectal malformation. The probe has a 260 cm cord with two electrically shrouded banana plugs for attachment to the Peña Muscle Stimulator (PS2, sold separately). The probe tip consists of two gold plated polished wire probes, 0.8 mm diameter and separated by 1.8 mm. The wire probes function as the bipolar stimulus electrodes when the PS2P Probe is connected to the PS2 Stimulator.
Who Else Makes It
Concentrated in Guangdong (25), Beijing (3), Jiangsu (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
| Shenzhen Jie Zhong Lian Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Suzhou Fast ATM Electric Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Hong Qiangxing (Shen Zhen) Electronics Limited | Shenzhen | Guangdong | Contract manufacturer | 19 |
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Guangzhou Xinbo Electronic Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 18 |
| Drtv Asia Ltd | Panyu Guangzhou | Guangdong | Specification developer | 16 |
Showing 12 of 33. All 33 manufacturers in China registered for Stimulator, Muscle, Powered
Record
| Listed by | Integra Neurosciences Implant (France) |
|---|---|
| FDA product code | IPF |
| Device type | Stimulator, Muscle, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5850 |
| Premarket notification | Exempt |
| Record published | 2016-08-08 |
| Record revised | 2024-03-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PS2P | Probe 17cm Length | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QB1 Nmes System | Motive Health, Inc. | 69 |
| MyndMove | Myndtec Inc | 44 |
| GEM-Stim | Gemore Technology Co., Ltd. | 38 |
| Chattanooga | DJO, LLC | 27 |
| ReGrasp | Rehabtronics, Inc. | 19 |
| Stimulation System | Edan Instruments, Inc. | 16 |
| e-vive II Nmes System | Motive Health, Inc. | 16 |
| L300 Go System | Bioness Medical, Inc. | 11 |
| Motive Knee System | Motive Health, Inc. | 9 |
| Ness H200® Wireless Hand Rehabilitation System | Bioness Medical, Inc. | 9 |
| BodyMed | Boxout, LLC | 8 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 7 |
Showing 12 of 204. All products under Stimulator, Muscle, Powered
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.