Duns Number:347303674
Device Description: Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also Single channel, transcutaneous neuromuscular stimulator for relief of dropped foot. Also cleared for gait re-education and similar applications plus physical therapy uses.
Catalog Number
00-001-0019
Brand Name
ODFS Pace XL
Version/Model Number
1.1
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
K171396
Product Code
GZI
Product Code Name
Stimulator, Neuromuscular, External Functional
Public Device Record Key
922ec1aa-5358-4c95-9862-49b8a895956e
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 22, 2018
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. | 1 |