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Myostim Model 6600

FDA 510(k)

Class II (US FDA 510(k))

510(k) K872753

by Medical Devices Inc.

Identifiers

510(k) Number
K872753 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 Myostim Model 6600 is a neuromuscular electrical stimulation (NMES) device, classified under the product code IPF (Physical Medicine). It is designed to stimulate muscle contraction through controlled electrical impulses, aiding in muscle re-education, strengthening, and rehabilitation for patients with neuromuscular impairments or post-injury recovery.

This device is intended for use in clinical settings such as physical therapy or rehabilitation facilities. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure safe and effective operation. The Myostim Model 6600 holds an FDA 510(k) clearance (K872753) under the Traditional clearance type, with a decision date of October 1, 1987. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What is the Myostim Model 6600 used for?

The Myostim Model 6600 is a neuromuscular electrical stimulation (NMES) device designed to stimulate muscle contraction through controlled electrical impulses. It is primarily used in clinical settings like physical therapy or rehabilitation facilities to aid in muscle re-education, strengthening, and recovery for patients with neuromuscular impairments or post-injury conditions. By mimicking natural nerve signals, it helps improve muscle function and supports rehabilitation programs.

Is the Myostim Model 6600 reusable or single-use?

The Myostim Model 6600 is supplied as a reusable medical instrument. Since it is intended for clinical use, it requires regular maintenance, cleaning, and calibration to ensure safe and effective operation. Reusability is common for durable medical devices like this, allowing for cost-effective use across multiple patients under proper infection control protocols.

Does the Myostim Model 6600 come with specific size or model variations?

The provided data specifies only the Myostim Model 6600 as the device reference, without additional size or model variations mentioned. If customization or multiple configurations are needed, it would depend on accessories or electrode options provided by the manufacturer. Always verify with the manufacturer for any available variations or accessories.

How should the Myostim Model 6600 be stored?

While the data does not specify storage instructions, reusable medical devices like the Myostim Model 6600 generally require storage in a clean, dry environment away from direct sunlight or extreme temperatures. It should be kept in a secure location to prevent damage and contamination. Follow manufacturer guidelines for any specific storage recommendations or maintenance schedules.

What regulatory clearance does the Myostim Model 6600 hold?

The Myostim Model 6600 holds an FDA 510(k) clearance under the product code IPF (Physical Medicine), with the clearance number K872753. This classification indicates it is substantially equivalent to a legally marketed device and was granted under the Traditional clearance type. The decision date for clearance was October 1, 1987.

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: MYOSTIM(TM), MODEL 6600 (K872753) — FDA 510(k) | Innolitics, PDF K872753 MYOSTIM(TM), MODEL 6600 - 510kdatabase.net, Myostim (tm), Model 6600 510 (k) FDA Premarket Notification K872753 ..., 510 (k) Premarket Notification, Establishment Registration & Device Listing - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medical Devices Inc.
FDA Applicant
Medical Devices, Inc.

Sources (1)

  • FDA 510(k) K872753 24 fields · synced Oct 1, 2026