Duns Number:833969186
Device Description: ThermaZone Range of Motion (ROM) Knee Brace with Advanced Heating / Cooling Therapy
Catalog Number
003-47
Brand Name
ThermaZone
Version/Model Number
003-47
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
-
Product Code
ILO
Product Code Name
Pack, Hot Or Cold, Water Circulating
Public Device Record Key
43bd83e7-0e6b-4fbc-aec7-1ba40012dd52
Public Version Date
August 30, 2022
Public Version Number
4
DI Record Publish Date
December 01, 2020
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |