Duns Number:831838391
Device Description: The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massa The Comfy Curve Massage Pro device is an electrically powered, vibrating therapeutic massager. The device consists of a memory foam pillow with a small internal motor, powered by (2) AA batteries (not included), that vibrates the entire pillow. The Comfy Curve Massage Pro is an OTC device that is intended to be used on the body for relief of minor aches and pains.
Catalog Number
-
Brand Name
Comfy Curve Massage Pro
Version/Model Number
CCPMP-MC3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
August 15, 2028
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
ISA
Product Code Name
Massager, Therapeutic, Electric
Public Device Record Key
68590752-1301-4272-ad57-955b6852dba9
Public Version Date
June 24, 2021
Public Version Number
1
DI Record Publish Date
June 16, 2021
Package DI Number
20850018026165
Quantity per Package
3
Contains DI Package
00850018026161
Package Discontinue Date
March 08, 2028
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |