Duns Number:084042331
Device Description: ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or stand ManaFlexx 2 is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditionsCompletely portable no wires or bulky devicesCan be placed anywhere treatment is desiredBattery operatedReusable - simply replace pads and batteries
Catalog Number
MFPAD
Brand Name
Ignite MD
Version/Model Number
Manaflexx2 Replaceable Pad
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)
Yes
Over the Counter (OTC)
-
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
e45e92f4-e3a1-4fcc-b849-d9d55dac65b3
Public Version Date
July 01, 2022
Public Version Number
1
DI Record Publish Date
June 23, 2022
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 | 128 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |