Duns Number:663211978
Device Description: The AWQ-104L w L-Digital Meter is the latest improved version of the multipurpose WQ-10 el 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.
Catalog Number
ED3923
Brand Name
AWQ-104L
Version/Model Number
ED3923
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K050989,K050989
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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
Package DI Number
34897076720010
Quantity per Package
12
Contains DI Package
14897076720016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |