Duns Number:699495401
Device Description: 120V/60Hz 110W. CALMING HEAT WEIGHTED MASSAGING HEATING PAD.3 Heat ,6 Vibration. This dev 120V/60Hz 110W. CALMING HEAT WEIGHTED MASSAGING HEATING PAD.3 Heat ,6 Vibration. This device complies with part 15 of FCC rules.
Catalog Number
CWT02106 –CWT47012-CWT05112
Brand Name
SHARPER IMAGE
Version/Model Number
CH2-6
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
78de8c85-5f95-4aac-ab40-10629c155ffa
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 2022
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. | 2 |