FDA UDI
In Commercial Distribution
🇺🇸 United States
OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System
DI: 00858703006399
·
Model: A007-533
·
ACCELERATED CARE PLUS CORP
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OmniCycle Elite 7 Inch Screen Motorized Therapeutic Exercise System
- Primary DI
- 00858703006399
- Version / Model
- A007-533
- Company Name
- ACCELERATED CARE PLUS CORP
- Labeler DUNS
- 828331616
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-21
- Public Version
- 1
- Public Version Date
- 2024-10-29
- Public Version Status
- New
- Public Device Record Key
- 1b96ac05-1445-4d02-b2be-ecd27cb01a9c
Device Description
Motorized therapy cycle with a 7 inch screen that can connect to the OmniTour system
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36313 | Continuous passive motion joint exerciser | A mains electricity (AC-powered) device designed to continuously move one or more joints (shoulder, elbow, wrist, hand/fingers, hip, knee, ankle, and/or feet/toes) without patient assistance during continuous passive motion (CPM) exercise therapy. It typically consists of a motorized carriage with pads and straps to hold and support the limb/digit, and an electrical control unit for the healthcare professional to set the variable range of motion and motion speed; it may additionally be intended to provide active resistance. It is typically intended to stimulate articular tissues, circulation of synovial fluid, reduce joint oedema, and provide neuromuscular and/or coordination training. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858703006399 | GS1 |
Customer Contacts
- Phone
- 1-800-350-1100
- [email protected]