Multi-Mode Stimulator - The Elite Medical Supply of NY PMD2000 Multi-Mode - ELITE MEDICAL SUPPLY OF NY

Duns Number:608469891

Device Description: The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a batte The Elite Medical Supply of NY PMD2000 Multi-Mode Stimulator (MMS) (the Device) is a battery and 110V wall adapter powered electrotherapy devices intended for clinic and outpatient rehabilitative therapy, acute postoperative care and home use for patients suffering from a variety of chronic pain issues. Prescribed by a physician, it gives the clinician a variety of electrotherapy modes to treat a range of indications. The Device is designed for clinician and patient ease of use and provides safe and effective dispensing of the desired electrotherapy treatment. The Intended Use Environment is Home Healthcare but the Device can also be used in a Chiropractic, Physical Therapy or Pain Management Clinic.The Device uses a tactile button user interface for control of the operating system and therapy amplitude settings. The Device has a liquid crystal character display which provides information to the user and displays the current therapy settings.The Device’s therapeutic output is transmitted through the patient lead wires to the cutaneous hydrogel electrodes affixed to the user’s skin. The energy generated by the Device is conveyed, via the patient lead wires and cutaneous electrodes, through the patients skin to excite either the underlying motor nerves to elicit involuntary muscle contractions or the sensory nerves to manage pain.

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More Product Details

Catalog Number

-

Brand Name

Multi-Mode Stimulator

Version/Model Number

PMD2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K042881,K042881

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

e46af1a1-20a5-4350-9439-2d4abf26f739

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

March 19, 2018

Additional Identifiers

Package DI Number

00860019001647

Quantity per Package

1

Contains DI Package

00860019001630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carrying case

"ELITE MEDICAL SUPPLY OF NY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4