Duns Number:831001404
Device Description: Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medic Stimulator, nerve, transcutaneous, for pain relief. The ReBuilder is an intelligent medical device that relieves chronic pain by calming erratic nerve signals, strengthening muscles, and restoring local blood flow.
Catalog Number
-
Brand Name
ReBuilder
Version/Model Number
2407
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
K874085
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
c511753f-ddea-4d23-adcf-c00362d6043b
Public Version Date
May 23, 2019
Public Version Number
4
DI Record Publish Date
December 28, 2016
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. | 2 |