Incontinence Treatment Device LT2061
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171430 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 Incontinence Treatment Device LT2061 is an electrical, non-implantable stimulator designed to manage urinary incontinence. It delivers controlled electrical impulses to the sacral nerves, helping to restore bladder function and reduce involuntary urine leakage in patients with neurogenic or idiopathic incontinence.
This device is intended for non-invasive external use and is classified as a Class II medical device under FDA regulations (21 CFR 876.5320). Supplied as a single-use or reusable system (depending on electrode configuration), it requires no sterilisation and is compatible with MRI environments when used as directed. Authorised under FDA 510(k) clearance (K171430), it is distributed with user manuals and regulatory documentation for clinical application in urology and gastroenterology settings.
Frequently asked questions
What is the LT2061 Incontinence Treatment Device used for?
The LT2061 is designed to manage urinary incontinence by delivering controlled electrical impulses to the sacral nerves. This helps restore bladder function and reduce involuntary urine leakage in patients with neurogenic (nerve-related) or idiopathic (unknown cause) incontinence. It is intended for non-invasive external use and is classified as a Class II medical device under FDA regulations.
Is the LT2061 device single-use or reusable?
The LT2061 can be supplied as either a single-use or reusable system, depending on the electrode configuration. This flexibility allows clinicians to choose the most suitable option based on clinical needs and usage frequency. The device does not require sterilization, simplifying its use in clinical settings.
Can the LT2061 be used in an MRI environment?
Yes, the LT2061 is compatible with MRI environments when used as directed. This is because it is a non-implantable, external device that does not contain metallic components or materials that would interfere with MRI scans. Always follow the manufacturer’s instructions for safe use in MRI settings.
What medical specialties commonly use the LT2061?
The LT2061 is primarily used in urology and gastroenterology settings. These specialties often address conditions related to bladder function and incontinence, making the device particularly relevant for patients requiring non-invasive treatment options for urinary control.
What regulatory approval does the LT2061 have?
The LT2061 has received FDA 510(k) clearance under the reference number K171430. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets FDA safety and effectiveness requirements for non-invasive electrical stimulators used in incontinence treatment.
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: Incontinence Treatment Device, Model LT2061 (K171430) — FDA 510(k ..., LT2061 Incontinence Treatment Device User... - FCC ID 2AKMI-LT2061, FCC ID 2AKMI-LT2061 - Incontinence Treatment Device, Incontinence Treatment Device, Model LT2061 - FDA 510(k) K171430, LT2061 Incontinence Treatment Device User... - FCC ID 2AKMI-LT2061
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171430 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (1)
- FDA 510(k) K171430 24 fields · synced Oct 1, 2026