Tri-Wave Combination Stimulator - The Elite Medical Supply of NY EMS100 Tri-Wave - ELITE MEDICAL SUPPLY OF NY

Duns Number:608469891

Device Description: The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (the Device) is a ba The Elite Medical Supply of NY EMS100 Tri-Wave Combination Stimulator (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 ManagementClinic.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

Tri-Wave Combination Stimulator

Version/Model Number

EMS100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K171387,K171387

Product Code Details

Product Code

IPF

Product Code Name

Stimulator, Muscle, Powered

Device Record Status

Public Device Record Key

bcdac13c-4a6c-4195-b75e-5d9e95530741

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

March 16, 2018

Additional Identifiers

Package DI Number

00860019001623

Quantity per Package

1

Contains DI Package

00860019001609

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