Duns Number:827221698
Device Description: App Control for ACRL-9100 Device v.0
Catalog Number
-
Brand Name
AccuRelief
Version/Model Number
ACRL-9100APP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 27, 2019
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
0db96407-cdb1-4a00-920f-ad48914e2fc1
Public Version Date
February 19, 2021
Public Version Number
7
DI Record Publish Date
July 19, 2017
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 | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |