AccessGUDID - DEVICE: AWQ-104L (14897076720016)

GUDID

Device Identifier (DI) Information

Brand Name: AWQ-104L
Version or Model: ED3923
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ED3923
Company Name: TENS PLUS INDUSTRIAL COMPANY

Primary DI Number: 14897076720016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 663211978 *Terms of Use

Device Description: The AWQ-104L w L-Digital Meter is the latest improved version of the multipurpose WQ-10 electro-therapy series from China, now with 4 outputs and large 0.5" x 0.9" LCD digital meter. The AWQ-104L is able to display and fine tune frequency selection through two separate ranges: 1 to 100 Hz (low) and 10 to 1,000 Hz (High). Unit also features: 4 independently controlled output channels which provide stimulation to 8 needles, polarity reversal [i.e. tonification (+) and sedation (-)] switches for each channel, Hi/Low voltage switch, and 2 frequency ranges (X1, X10). New integrated circuitry assures no interference or crossover. The AWQ-104L is also capable of delivering micro-current when the intensity is set just below the sensorial threshold level. Powered by 9 volt battery. Three adjustable pulse modes are also offered: continuous, intermittent (discontinuous), and dense-disperse. Accessories include 5" long pen shaped treatment probe with hand ground pole and wire, 4 sets of alligator clip wires, sturdy carrying case, 9-volt battery, and instructions. 1-year warranty from date of purchase.

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):	Yes
Over the Counter (OTC):	No
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?
35372	Analgesic transcutaneous electrical nerve stimulation system	An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.	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 [?]
K050989	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: a45fca27-17d6-42fc-8443-e1aa05bf84fc
Public Version Date: October 23, 2019
Public Version Number: 4
DI Record Publish Date: August 04, 2016