Duns Number:698505802
Device Description: Offers people of all ages, gender and abilities the benefits to improve the body’s overall Offers people of all ages, gender and abilities the benefits to improve the body’s overall performance, flexibility, and range of motion to prevent injury and thus improve overall well being.
Catalog Number
-
Brand Name
TB12 VIBRATING PLIABILITY SPHERE
Version/Model Number
VBALL-BLK-02A
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"
Yes
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
ce0df728-43db-4828-bf4b-e9729714b887
Public Version Date
January 20, 2021
Public Version Number
1
DI Record Publish Date
January 12, 2021
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 | 3 |