Duns Number:987904356
Device Description: The SLENDERTONE Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator int The SLENDERTONE Evolve Abs, Type 735 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. It is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.
Catalog Number
735-5000
Brand Name
Slendertone Evolve Abs
Version/Model Number
735
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
NGX
Product Code Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Public Device Record Key
94ee0aa3-3cf2-46c1-8ff9-47fe2a4c3822
Public Version Date
April 05, 2021
Public Version Number
1
DI Record Publish Date
March 26, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |