AccessGUDID - DEVICE: CMF (00888912011488)

GUDID

Device Identifier (DI) Information

Brand Name: CMF
Version or Model: OL1000 Dual Coil
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-203-0001
Company Name: DJO, LLC

Primary DI Number: 00888912011488
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081840873 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35463	Patient-worn bone growth electromagnetic stimulator	A battery-powered, body-worn device designed to apply an electrical stimulus directly to bone to promote bone formation (i.e., osteogenesis). It is intended to generate an electromagnetic (EM) field (and its associated induced voltage effects) around a fracture or fusion site; it is not intended to apply an electric current directly to the body. The device is used as an alternative to bone grafting for non-union fractures (a condition in which the ends of a fractured bone fail to unite), and as a spinal fusion adjunct in treating degenerative vertebral diseases. It is also known as an osteogenesis stimulator.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LOF	Stimulator, Bone Growth, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90ba5060-c53e-42e2-ad47-71474b304b9e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2014