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TensCare iTouch Sure Model ITS

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K103698

by TensCare Ltd

Identifiers

510(k) Number
K103698 FDA 510(k)
FDA Product Code
KPI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5320 FDA 510(k)
Regulation Number
876.5320 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TensCare iTouch Sure Model ITS is a non-implantable electrical stimulator designed for neuromuscular re-education of the pelvic floor muscles. It is classified as a Class II device under FDA regulations and is intended for use in managing stress, urge, and mixed urinary incontinence in women by delivering targeted electrical stimulation.

This device is supplied as a reusable, non-sterile medical instrument and is regulated under FDA 510(k) clearance (K103698) and the EU Medical Device Regulation (MDR). It is intended for use in clinical settings such as gastroenterology and urology, adhering to regulatory standards for electrical stimulators (regulation number 876.5320). No MRI safety information or specific storage conditions are provided in the available data.

Frequently asked questions

What clinical specialties is the TensCare iTouch Sure Model ITS primarily used in, and why is this device relevant to those fields?

The TensCare iTouch Sure Model ITS is primarily used in gastroenterology and urology clinical settings. It is designed for neuromuscular re-education of the pelvic floor muscles, which directly addresses conditions like stress, urge, and mixed urinary incontinence in women. These specialties benefit from its targeted electrical stimulation, helping patients regain pelvic floor control and improve incontinence management.

Is the TensCare iTouch Sure Model ITS intended for single-use or reusable applications, and what does this mean for clinical workflows?

The TensCare iTouch Sure Model ITS is reusable and non-sterile, meaning it is intended for repeated use within clinical settings. This design allows for cost-effective deployment across multiple patients, though proper cleaning and maintenance protocols must be followed to ensure safety and hygiene between uses.

What regulatory pathways does the TensCare iTouch Sure Model ITS follow in the U.S. and Europe, and what does this imply for compliance?

In the U.S., the device is cleared via FDA 510(k) (K103698) under Class II regulations, with a substantially equivalent determination for non-implantable electrical stimulators. In Europe, it complies with the EU Medical Device Regulation (MDR). Both pathways ensure it meets strict safety and performance standards for neuromuscular stimulation devices.

Are there specific storage requirements or warnings for the TensCare iTouch Sure Model ITS, and what should clinicians consider before use?

The provided data does not specify storage conditions or MRI safety information for the TensCare iTouch Sure Model ITS. Clinicians should ensure the device is stored in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is non-sterile and reusable, proper disinfection protocols must be followed before each use to maintain hygiene.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TENSCARE ITOUCH SURE MODEL ITS (K103698) — FDA 510 (k) | Innolitics, TensCare itouch sure Instructions For Use Manual, iTouch Sure Pelvic Floor Exerciser for Bladder Leaks || TensCare, ITOUCH SURE Manual | TensCare Pelvic Floor Stimulator | Manualzz

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
TensCare Ltd
FDA Applicant
Tenscare, Ltd.

Sources (2)

  • FDA 510(k) K103698 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026