Duns Number:675938472
Device Description: Use for symptomatic relief and management of chronic pain and/or as adjunctive treatment i
Catalog Number
-
Brand Name
Johari Digital Healthcare Ltd.
Version/Model Number
IF4250D
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K024036
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
8a8e66b0-0032-46d2-bfbf-3cdbdafe0a3d
Public Version Date
February 19, 2021
Public Version Number
4
DI Record Publish Date
June 14, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |
| 3 | A medical device with high risk that requires premarket approval | 1 |