Identifiers
- 510(k) Number
- K190988 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The GIM-STIM OTC TENS/EMS System is a dual-channel transcutaneous electrical nerve stimulator designed for body training applications. It is available in models GM510, GM511, GM520, GN530, and GM540. The device provides electrical stimulation for various body areas including ABS, arms, legs, and buttocks.
The GIM-STIM OTC TENS/EMS System is supplied as an over-the-counter device that does not require a prescription. It is regulated under 21 CFR 882.5890 and received FDA 510(k) clearance on August 16, 2019, with K190988. The device is manufactured by Gemore Technology Co, Ltd. in Taiwan.
Frequently asked questions
What is the GIM-STIM OTC TENS/EMS System used for?
The GIM-STIM OTC TENS/EMS System is a dual-channel transcutaneous electrical nerve stimulator designed for body training applications. It provides electrical stimulation for various body areas including ABS, arms, legs, and buttocks to help with muscle training and conditioning.
Is the GIM-STIM OTC TENS/EMS System reusable or single-use?
The GIM-STIM OTC TENS/EMS System is supplied as an over-the-counter device that does not require a prescription. It is designed for repeated use as a personal training device, though specific electrode pads may have their own single-use or reuse instructions depending on the type.
What models are available for the GIM-STIM OTC TENS/EMS System?
The GIM-STIM OTC TENS/EMS System is available in five different models: GM510, GM511, GM520, GN530, and GM540. Each model may have specific features or specifications tailored to different body training applications and user preferences.
What is the regulatory status of the GIM-STIM OTC TENS/EMS System?
The GIM-STIM OTC TENS/EMS System is regulated under 21 CFR 882.5890 and received FDA 510(k) clearance on August 16, 2019, with K number K190988. It is classified as substantially equivalent to predicate devices in the neurology product code category NUH.
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: K190988 - GIM-STIM OTC TENS/EMS System - Neurology, GIM-STIM OTC TENS/EMS System (K190988) — FDA 510(k) | Innolitics, OTC EMS for ABS,Arm/Leg and Buttock | Products > OTC TENS/EMS series ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190988 | Class II | Active |
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Manufacturer
- Manufacturer
- Gemore Technology Co., Ltd.
- FDA Applicant
- Gemore Technology Co, Ltd.
Sources (1)
- FDA 510(k) K190988 24 fields · synced Oct 1, 2026