Identity
- Trade Name
- ManaMed FDA UDI
- Generic Name
- Shoulder immobilizer/orthosis, reusable FDA UDI
- Device Name
- 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 Benefits Universal sizing and can be applied to the left or right side Breathable material for patient comfort Provides support for shoulder surgeries or conservative care of shoulder injuries Passive Machine The pneumatic passive machine included with the shoulder sling To be worn to promote abduction movement with internal and external rotation Ability to achieve various abduction angles from 30 to 90 degrees The machine is portable, wireless, and rechargeable Common Examples of Use To promote small movements after rotator cuff, arthroscopic, and anterior repairs To prevent frozen shoulder Shoulder instabilities To be worn to eliminate the need for contracture braces FDA UDI
- Model / Reference
- Bionic Sling Air Shoulder FDA UDI
- Description
- 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 Benefits Universal sizing and can be applied to the left or right side Breathable material for patient comfort Provides support for shoulder surgeries or conservative care of shoulder injuries Passive Machine The pneumatic passive machine included with the shoulder sling To be worn to promote abduction movement with internal and external rotation Ability to achieve various abduction angles from 30 to 90 degrees The machine is portable, wireless, and rechargeable Common Examples of Use To promote small movements after rotator cuff, arthroscopic, and anterior repairs To prevent frozen shoulder Shoulder instabilities To be worn to eliminate the need for contracture braces FDA UDI
Identifiers
- Catalog Number
- BS001 FDA UDI
- Primary DI / UDI-DI
- 00810113680170 FDA UDI
- FDA Product Code
- ILI FDA UDI
- GMDN Term
- Shoulder immobilizer/orthosis, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3640 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ManaMed by Manamed Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Manamed Llc
Sources (1)
- FDA UDI be98544b-03c8-44d7-a719-750165e34718 36 fields · synced May 30, 2026