LT3000 Combo Stimulator, LT3001 TENS Stimulatory, LT3002 EMS Stimulator
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K100117 FDA 510(k)
- FDA Product Code
- IPF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5850 FDA 510(k)
- Regulation Number
- 890.5850 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LT3000 Combo Stimulator, LT3001 TENS Stimulatory, and LT3002 EMS Stimulator are neurostimulation devices designed for physical medicine applications. These devices deliver transcutaneous electrical nerve stimulation (TENS) and electromyostimulation (EMS) to manage pain and promote muscle activation, respectively, through controlled electrical impulses.
These devices are supplied as reusable medical equipment and are intended for use in clinical or home settings. They are classified under the product code IPF and have received FDA 510(k) clearance as substantially equivalent to existing devices, alongside compliance with the Medical Device Directive (MDD). No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
Are these devices meant for single-use or can they be reused in clinical or home settings?
These devices are explicitly labeled as reusable medical equipment, meaning they are designed for repeated use in both clinical and home settings. Since they are not described as disposable or sterile, they should be cleaned and maintained according to manufacturer guidelines between uses.
What types of electrical stimulation do these devices provide, and how are they clinically applied?
The LT3000 Combo Stimulator, LT3001 TENS Stimulatory, and LT3002 EMS Stimulator deliver transcutaneous electrical nerve stimulation (TENS) and electromyostimulation (EMS). TENS is used primarily for pain management by targeting nerve pathways, while EMS is designed to promote muscle activation, making them suitable for physical medicine applications like rehabilitation or chronic pain relief.
What regulatory pathways have these devices undergone, and how does that affect their use?
These devices received FDA 510(k) clearance under the product code IPF (Physical Medicine), with a decision of Substantially Equivalent (SESE) to existing devices. They also comply with the Medical Device Directive (MDD). This means they are legally marketed in the U.S. and EU under those regulatory frameworks, but their use remains governed by clinical guidelines and professional judgment.
Are there different models available, and if so, how do they differ in function?
Yes, there are three models: the LT3000 Combo Stimulator (combining TENS and EMS), the LT3001 TENS Stimulatory (focused solely on pain relief via TENS), and the LT3002 EMS Stimulator (targeting muscle activation). The Combo model offers versatility for dual applications, while the others specialize in specific therapeutic needs.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K100117 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (2)
- FDA 510(k) K100117 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026