Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171978 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 Combo Stimulator MT9000, Combo Stimulator LT7102, and TENS Stimulator InTENSity 10 are transcutaneous electrical nerve stimulators (TENS) and neuromuscular electrical stimulators (NMES) designed for pain relief and muscle stimulation. These devices deliver electrical current via skin-applied electrodes to modulate pain signals and stimulate muscle contractions, addressing chronic intractable pain, post-traumatic pain, and post-surgical pain.
These devices are intended for clinical use in physical medicine settings and are supplied as reusable medical equipment. The Combo Stimulator MT9000 and LT7102, along with the TENS Stimulator InTENSity 10, have received FDA 510(k) clearance and comply with the Medical Device Directive (MDD). They are classified under product code IPF and are regulated as Class 2 devices under the Traditional 510(k) pathway.
Frequently asked questions
Are these devices meant for home use or are they strictly for clinical settings like physical medicine offices?
These devices are explicitly designed for clinical use in physical medicine settings and are supplied as reusable medical equipment. While they can deliver transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES), their regulatory classification and intended use align with professional healthcare environments, not consumer/home use.
How do I know which model is right for my clinic’s needs—MT9000, LT7102, or InTENSity 10? Are there differences in their capabilities?
The Combo Stimulator MT9000 and LT7102 are both TENS/NMES devices, while the TENS Stimulator InTENSity 10 focuses solely on TENS for pain relief. The MT9000 and LT7102 offer dual functionality (pain modulation *and* muscle stimulation), making them suitable for post-surgical or post-traumatic recovery where muscle re-education is needed. The InTENSity 10 is simpler, targeting chronic or intractable pain without muscle stimulation.
Are these devices single-use or reusable? How should they be maintained?
These devices are reusable medical equipment, meaning they are built for repeated use in clinical settings. Maintenance instructions are not provided in the data, but reusable stimulators typically require periodic cleaning (e.g., with alcohol wipes), electrode pad replacement, and calibration checks per manufacturer guidelines to ensure safety and efficacy.
What regulatory pathway did these devices follow to gain clearance, and how does that affect their use?
The Combo Stimulator MT9000, LT7102, and InTENSity 10 received FDA 510(k) clearance under the Traditional pathway, classified as Class 2 devices with product code IPF (Physical Medicine). This means they were deemed *substantially equivalent* to a predicate device already on the market, ensuring compliance with the Medical Device Directive (MDD). Clinically, this classification confirms their suitability for professional use in pain management and muscle stimulation.
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: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator ..., K171978 FDA 510 (k) - Combo Stimulator MT9000, Combo Stimulator Mt9000, Combo Stimulator Lt7102, Tens Stimulator ...
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 | K171978 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Dongdixin Technology Co., Ltd.
Sources (2)
- FDA 510(k) K171978 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026