Ultima NEO - TENS stands for Transcutaneous Electrical Nerve - EasyMed Instruments Co., Ltd.

Duns Number:526951168

Device Description: TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system i TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:• Relaxation of muscle spasm;• Increasing local blood circulation and muscle re-education;• Prevention or retardation of disuse atrophy;• Prevention of venous thrombosis of the calf muscles immediately after surgery;• Maintaining or increasing range of motion.MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:• Symptomatic relief of chronic intractable pain.

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More Product Details

Catalog Number

-

Brand Name

Ultima NEO

Version/Model Number

Ultima NEO

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

-

Product Code Details

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

bca96ddc-e76f-4669-b843-92264aaf12be

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EASYMED INSTRUMENTS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25