Duns Number:080930531
Device Description: THERASOUND EVO, THERAPY HAMMER, AUTOSOUND, LASER MODULE, LEAD CORDS, 5CM GELSHOTS & ADAPTO THERASOUND EVO, THERAPY HAMMER, AUTOSOUND, LASER MODULE, LEAD CORDS, 5CM GELSHOTS & ADAPTORS
Catalog Number
-
Brand Name
THERASOUND EVO PACKAGE
Version/Model Number
410-020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2018
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
-
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
9a8049b1-3006-420b-a726-254dd8865a05
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
November 21, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 47 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 449 |