AccessGUDID - DEVICE: EmeTerm 2 (06971760280114)

GUDID

Device Identifier (DI) Information

Brand Name: EmeTerm 2
Version or Model: YF-ZTY-E2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WAT Medical Technology Inc.

Primary DI Number: 06971760280114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544509582 *Terms of Use

Device Description: TENS device-EmeTerm 2 generates the electric pulses with highly specific waveforms, frequency and amplitude to stimulate the median nerve. The accurate pulse signals provide relief through electrical stimulation of the nerves in the patient’s wrist.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
63388	Anti-nausea transcutaneous electrical nerve stimulation wristband	An electrically-powered device designed to be worn on the wrist of a patient to apply electrical stimuli to the median nerve through the skin (transcutaneously), to help relieve the sensation of nausea caused by various conditions [e.g., pregnancy (morning sickness), motion (travel sickness), chemotherapy]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K220503	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90b22858-5418-4cbd-a076-229070c52a88
Public Version Date: August 31, 2022
Public Version Number: 1
DI Record Publish Date: August 23, 2022