Reletex - Reletex from Reliefband is a prescription device - RELIEFBAND TECHNOLOGIES LLC

Duns Number:080294073

Device Description: Reletex from Reliefband is a prescription device that is applied to the underside of the w Reletex from Reliefband is a prescription device that is applied to the underside of the wrist. Reletex emits electrical pulses that stimulate the underlying median nerve. These generated neural pulses interact with the CNS and Emetic Center in the brain to modulate the signals causing nausea and vomiting. It is intended for use as: (1) a treatment of nausea and vomiting (NV) due to chemotherapy; (2) a treatment of nausea and vomiting due to pregnancy (NVP) or morning sickness; and (3) an adjunct to antiemetics in reducing post-operative nausea. Reletex can function with its included set of non-replaceable/non-rechargeable batteries for approximately 150 hours when used on setting 3. In all such instances, Reletex is for single-patient use.

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More Product Details

Catalog Number

PCN3

Brand Name

Reletex

Version/Model Number

PCN3

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

Yes

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

K994387,K994387,K994387

Product Code Details

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

dc4ec6d2-94cb-4e4e-a58d-ee702a65b2e4

Public Version Date

July 07, 2021

Public Version Number

1

DI Record Publish Date

June 29, 2021

Additional Identifiers

Package DI Number

20661168300018

Quantity per Package

6

Contains DI Package

00661168300014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner

"RELIEFBAND TECHNOLOGIES LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2