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Tenscare

FDA UDI

Class II (US FDA UDI)

by Tenscare Limited

Identity

Trade Name
Tenscare FDA UDI
Generic Name
Perineal orifice incontinence-control electrical stimulation system FDA UDI
Device Name
The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use. FDA UDI
Model / Reference
Sure+ FDA UDI
Description
The Sure + is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. The Sure + is intended for OTC use. FDA UDI

Identifiers

Catalog Number
K-SURE+USA FDA UDI
Primary DI / UDI-DI
05033435134458 FDA UDI
510(k) Number
K191312 FDA UDI
FDA Product Code
KPI FDA UDI
GMDN Term
Perineal orifice incontinence-control electrical stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Perineal orifice incontinence-control electrical stimulation system

Tenscare by Tenscare Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Perineal orifice incontinence-control electrical stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tenscare Limited

Sources (1)

  • FDA UDI a3c0c88a-6dbe-4ea7-8857-a6e453e2cccb 36 fields · synced May 29, 2026