Primary Device ID | 05033435132171 |
NIH Device Record Key | 5a5e9dee-e75a-457f-a8d3-d661e96dba8e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EmbaGYN |
Version Model Number | itouch Sure |
Catalog Number | K-EMBAGYN |
Company DUNS | 569403736 |
Company Name | TENSCARE LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05033435132171 [Primary] |
KPI | Stimulator, Electrical, Non-Implantable, For Incontinence |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-02-15 |
05033435136933 - TensCare | 2024-08-02 Form Duo is a variant of the Perfect EMS medical device and is identical to the Form unit but comes with two stimulators. It ha |
05033435138920 - TensCare | 2024-08-01 The Ova3 is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free peri |
05033435134090 - TensCare | 2024-01-24 The Ova+ is a non-invasive small and convenient unit that can be worn under clothing to provide safe, continuous, drug-free peri |
05033435136209 - TensCare | 2023-11-13 Unifit combines the treatment capabilities of a TENS device, an EMS or NMES device, and a relaxing massage stimulator in one uni |
05033435135646 - TensCare | 2023-11-01 The Unicare is a powered muscle stimulator used for strengthening the pelvic floor muscles. It sends a gentle stimulation (simil |
05033435133796 - TensCare | 2023-10-12 Shockwave is a solenoid drive activates a bullet body inside the therapeutic handle. When the bullet body collides with the ther |
05033435120413 - TensCare | 2023-09-11 The KneeStim Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your knee, with an intended u |
05033435000722 - TensCare | 2023-09-08 The iGlove Garment Electrode, is a pack of 2 reusable garment electrodes designed for wearing on your hands, with an intended us |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EMBAGYN 85415453 4236257 Dead/Cancelled |
EXELTIS FRANCE 2011-09-06 |
EMBAGYN 77827971 not registered Dead/Abandoned |
CHEMO ESPAÃA, S.L. 2009-09-16 |