Duns Number:034446946
Device Description: HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.
Catalog Number
-
Brand Name
HotRock
Version/Model Number
HR-001
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
-
Product Code
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
dd89019b-5a0b-440e-b2e0-e6c4d35d02c7
Public Version Date
August 20, 2020
Public Version Number
2
DI Record Publish Date
June 16, 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 | 1 |