Electronic Muscle Stimulator Model EMS-1C/EMS-2C
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K960457 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 Electronic Muscle Stimulator Model EMS-1C/EMS-2C is a device designed for the evaluation and treatment of muscle dysfunction resulting from peripheral and central nervous system disorders. It functions to prevent muscle atrophy, relax muscle spasms, and facilitate muscle re-education.
The EMS-1C provides interrupted DC galvanic stimulation, while the EMS-2C offers both interrupted DC and pulsed faradic stimulation. Both models feature one-handed operation for current adjustment, active probe positioning, and on-off control. This device has received FDA 510k clearance.
Frequently asked questions
What is the difference between the EMS-1C and EMS-2C models?
The EMS-1C model is designed to provide interrupted DC galvanic stimulation. The EMS-2C model offers more versatility by providing both interrupted DC and pulsed faradic stimulation, allowing for different therapeutic approaches to muscle dysfunction.
What clinical conditions is this stimulator intended to treat?
This device is indicated for the evaluation and treatment of muscle dysfunction that results from central or peripheral nervous system disorders. It is specifically used to help prevent muscle atrophy, relax muscle spasms, and assist in muscle re-education.
How is the device operated during treatment?
Both models are designed for ease of use, featuring one-handed operation. This allows the clinician to manage current adjustment, active probe positioning, and on-off control simultaneously, which facilitates efficient application during patient treatment.
What is the regulatory status of this muscle stimulator?
The Electronic Muscle Stimulator Model EMS-1C/EMS-2C has received FDA 510k clearance. It was determined to be substantially equivalent to existing devices under the K960457 submission, falling under the physical medicine advisory committee.
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: EMS | Muscle Stimulator, Electronic Muscle Stimulator ... - Med Labs, Inc, E-Z Call, EZ Call, EZ-Call | Med Labs, Inc., Buy Med Labs EMS-1C, EMS-2C Electronic Muscle Stimulators
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K960457 | Class II | Active |
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Manufacturer
- Manufacturer
- Med Labs, Inc.
Sources (1)
- FDA 510(k) K960457 24 fields · synced Sep 23, 2026