EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in…
EmbaGYN Pelvic Floor Exerciser is a portable, battery operated electrical muscle stimulator. EmbaGYN is indicated for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress, urge, and mixed urinary incontinence. It is designed to be extremely easy to use, and is intended for daily use by the patient in their own home. The EmbaGYN is supplied with a Liberty vaginal electrode that may not be sterilised and is intended for single patient use.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1).
Record
Regulatory record for EmbaGYN | Listed by | Tenscare Ltd., United Kingdom |
| FDA product code | KPI |
| Device type | Stimulator, Electrical, Non-Implantable, For Incontinence |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5320 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-02-15 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
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.