Identifiers
- 510(k) Number
- K102178 FDA 510(k)
- FDA Product Code
- FMF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5860 FDA 510(k)
- Regulation Number
- 880.5860 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The EasyTouch Glucose Monitoring System is a blood glucose monitoring device designed to obtain blood samples for testing blood sugar levels. It allows testing from multiple sites including the forearm, palm (ventral or dorsal hand), or fingertips. The system includes a meter, test strips, and lancets for use in glucose measurement.
The device is supplied by MHC Medical Products and is intended for use in home and clinical settings. It is distributed through wholesalers and available via retail pharmacy channels. The system is designed for single-use components with appropriate storage conditions as specified by the manufacturer. It is regulated under FDA 510(k) clearance with product code FMF.
Frequently asked questions
What is the EasyTouch Glucose Monitoring System used for?
It is designed to obtain blood samples for testing blood sugar levels. The system allows testing from multiple sites including the forearm, palm (ventral or dorsal hand), or fingertips, making it suitable for both home and clinical settings.
What components are included in the EasyTouch system?
The system includes a meter, test strips, and lancets. These components work together to enable accurate glucose measurement from various body sites as specified by the manufacturer.
Is the EasyTouch device intended for single or multiple use?
The system is designed for single-use components. This means that parts such as lancets and possibly test strips are intended for one-time use to ensure hygiene and accuracy, following the manufacturer's guidelines.
How is the EasyTouch system supplied and distributed?
It is supplied by MHC Medical Products and distributed through wholesalers and available via retail pharmacy channels. This ensures accessibility for both healthcare providers and patients in home care settings.
What are the storage requirements for the EasyTouch system?
The device requires appropriate storage conditions as specified by the manufacturer. Users should follow the provided guidelines to maintain the integrity and functionality of the meter, test strips, and lancets.
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: EasyTouch Glucose Monitoring System - MHC Medical Products, LLC, MHC Medical Products, LLC, Easytouch syringes Premium Website, EasyTouch Insulin Syringes and Needles | EasyTouch Products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102178 | Class II | Active |
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Manufacturer
- Manufacturer
- MHC Medical Products
Sources (1)
- FDA 510(k) K102178 24 fields · synced Sep 24, 2026