Duns Number:341936227
Device Description: This product is an over-the-counter powered exerciser emitting very bright light.
Catalog Number
-
Brand Name
KBL beautyShaper
Version/Model Number
T3/50-180-c
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
BXB
Product Code Name
Exerciser, Powered
Public Device Record Key
da5e3934-d5c7-4126-b17d-20b7ff0ef2fa
Public Version Date
December 18, 2020
Public Version Number
1
DI Record Publish Date
December 10, 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 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |