Duns Number:084042331
Device Description: The Bionic Sling is a universal shoulder sling with a continuous passive machine to promot The Bionic Sling is a universal shoulder sling with a continuous passive machine to promote small movements after shoulder surgeries to help patients recover quicker.Features and BenefitsUniversal sizing and can be applied to the left or right sideBreathable material for patient comfortProvides support for shoulder surgeries or conservative care of shoulder injuriesPassive MachineThe pneumatic passive machine included with the shoulder slingTo be worn to promote abduction movement with internal and external rotationAbility to achieve various abduction angles from 30 to 90 degreesThe machine is portable, wireless, and rechargeableCommon Examples of UseTo promote small movements after rotator cuff, arthroscopic, and anterior repairsTo prevent frozen shoulderShoulder instabilitiesTo be worn to eliminate the need for contracture braces
Catalog Number
BS001
Brand Name
ManaMed
Version/Model Number
Bionic Sling Air Shoulder
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILI
Product Code Name
Sling, Arm
Public Device Record Key
be98544b-03c8-44d7-a719-750165e34718
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 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 |