Duns Number:783518983
Device Description: Features:1.LCD screen2.2 output ports3.10-60 minutes adjustable4.Rechargeable built-in lit Features:1.LCD screen2.2 output ports3.10-60 minutes adjustable4.Rechargeable built-in lithium batteryFunctions:1.Eliminate body fatigue2.Relax muscles and joints3.Improve blood circulation4.Increase metabolism and preventmany work related symptomsSpecifications1.Power/voltage: 3.7V2.Massage issuing frequency: 1~110Hz3.Consumed current: 40mA4.Status adjustment: 6 kinds of status
Catalog Number
7188
Brand Name
Pro Comfort TENS Unit
Version/Model Number
SM9128
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
K121719,K121719
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
8946747a-51a5-4d4e-ad77-7c4f9b7a4983
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
November 15, 2017
Package DI Number
10850632007185
Quantity per Package
36
Contains DI Package
00850632007188
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |