Duns Number:663213551
Device Description: The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical The Gymform Abs-A-Round EMS Belt is FDA Class II 510k cleared intended to apply electrical stimulation transcutaneously to tone, firm, and temporarily strengthen muscles through using the electric current pulse generator and the noninvasive electrodes. The EMS belt is a battery powered muscle stimulator, an over-the-counter device indicated for using to stimulate healthy muscles to facilitate and improve muscle performance in the intended areas on the body, a complimentary way to perform muscular training.
Catalog Number
644812017445
Brand Name
Gymform Abs-A-Round
Version/Model Number
VDP0016
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 13, 2022
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K130074
Product Code
NGX
Product Code Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Public Device Record Key
9aaac11f-0c3d-4666-96d5-9cd2f385c8b8
Public Version Date
August 15, 2022
Public Version Number
3
DI Record Publish Date
November 02, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |