InTone®MV
InToneMV
7manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Dongdixin Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Netop Industrial Company Limited | Dongguan | Guangdong | Manufacturer | 14 |
| Shenzhen Changkun Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Easymed Instruments Co., Ltd. | Daliang, Shunde, Foshan | Guangdong | Contract manufacturer | 8 |
| Dolanvy (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Incontrol Medical, LLC, United States |
|---|---|
| FDA product code | KPI |
| Device type | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5320 |
| Establishment | Manufacturer |
| 510(k) | K134020 |
| Record published | 2016-10-03 |
| Record revised | 2023-06-02 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Handling environment temperature 0 to 54 °C; Handling environment humidity 15 to 95 % RH; Storage environment temperature -20 to 65 °C |
| Sizes | Length 51.4 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5000000A1 | Length 51.4 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Lifecare | Everyway Medical Instruments Co., Ltd. | 28 |
| EMC Evolution | EMC Evolution | 10 |
| Konmed | Shenzhen Konmed Technology Co., Ltd. | 8 |
| DLR | Dolanvy (Suzhou) Medical Technology Co., Ltd. | 8 |
| iSTIM | Everyway Medical Instruments Co., Ltd. | 7 |
| Pathway® | Prometheus Group OF NEW Hampshire Limited, THE | 6 |
| Everyway | Everyway Medical Instruments Co., Ltd. | 5 |
| Liberty | Utah Medical Products, Inc. | 4 |
| TensCare | Tenscare Ltd. | 4 |
| BTL Chair Applicator | Btl Industries, Ltd. | 3 |
| NeoControl | Magic Race LLC | 3 |
| Konmed /Pelvifine | Shenzhen Konmed Technology Co., Ltd. | 3 |
Showing 12 of 42. All products under Stimulator, Electrical, Non-Implantable, For Incontinence
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182022 | 2019-03-15 |
| K150183 | 2015-04-09 |
| K150180 | 2015-03-16 |
| K141158 | 2014-11-26 |
| K134020 | 2014-02-25 |
| K133826 | 2014-01-06 |
| K110179 | 2012-02-22 |
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.