Identity
- Trade Name
- CMF FDA UDI
- Generic Name
- Patient-worn bone growth electromagnetic stimulator FDA UDI
- Device Name
- The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown. FDA UDI
- Model / Reference
- OL1000 Single Coil Size 2 FDA UDI
- Description
- The OL1000 and OL1000 SC BONE GROWTH STIMULATORS are indicated for the noninvasive treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing. The OL1000 and OL1000 SC are portable, battery powered, microprocessor-controlled, noninvasive bone growth stimulators. The device is worn by a patient for 30 minutes a day and provides local electromagnetic field treatment for a non-healing fracture. The device produces very low energy combined static and dynamic electromagnetic fields on the order of the earth’s magnetic field. The device has a push button that starts the treatment and an audible tone to notify the patient that a treatment has started or has ended. A liquid crystal display (LCD) is utilized to display the status of the device, e.g., treatment record, daily treatment time countdown. FDA UDI
Identifiers
- Catalog Number
- 01-211-0002 FDA UDI
- Primary DI / UDI-DI
- 00888912161756 FDA UDI
- FDA Product Code
- LOF FDA UDI
- GMDN Term
- Patient-worn bone growth electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient-worn bone growth electromagnetic stimulator
Cmf by Djo, Llc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 III | Pending data |
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Manufacturer
- Manufacturer
- Djo, Llc
Sources (1)
- FDA UDI 619fe26d-dfeb-400a-bc5b-14e24aacdd44 35 fields · synced May 30, 2026