FDA UDI
In Commercial Distribution
🇺🇸 United States
EZ Stretch
DI: G566FRR000Z4
·
Model: FRR000
·
Full Range Rehab, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EZ Stretch
- Primary DI
- G566FRR000Z4
- Version / Model
- FRR000
- Company Name
- Full Range Rehab, LLC
- Labeler DUNS
- 801147484
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-06
- Public Version
- 1
- Public Version Date
- 2024-12-16
- Public Version Status
- New
- Public Device Record Key
- c9a9ca0c-5b25-40ef-a2d6-da178dc5ae3f
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 | G566FRR000Z4 | HIBCC |