Curatronic Ltd. 1/9/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
JAN 9, 2013
Via United Parcel Service
Ben Philipson, CEO
P.O. Box 1532
Hashmonaim, Israel 73127
Re: BioMove 3000, BioMove 5000, Curatron 2000 HT, Curatron 2000 XP, Curatron 2000PC & Curatron Ultra-Power 3-D Pulsed Electro-Magnetic Field Therapy
Refer to GEN0901250 when replying to this letter.
Dear Mr. Philipson:
The Food and Drug Administration (FDA) has learned that your firm is marketing the BioMove 3000, BioMove 5000, Curatron 2000 HT, Curatron 2000 XP, Curatron 2000PC, and Curatron Ultra-Power 3-D Pulsed Electro-Magnetic Field Therapy (PEMF) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act). Under section 201(h) of the Act, 21 U.S.C.§ 321(h), these products are devices, because they are intended for use in the diagnosis of disease or other conditions or in cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body. As explained below, these devices are being marketed without the required clearance or approval in violation of the Act.
Our records show that your firm submitted a premarket notification submission under section 510(k) of the Act, 21 U.S.C. § 360(k), for the BioMove 3000 [K042650] and BioMove 5000 [K080787]. FDA cleared the BioMove 3000 and 5000 with the following indications for use:
- Stroke rehabilitation by muscle re-education
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
However, your firm promotes and distributes the BioMove 3000 and 5000 for uses for which it does not have FDA clearance. Specifically, the Office of Compliance, in FDA’s Center for Devices and Radiological Health, reviewed your firm’s website, www.biomove.com, on December 19, 2012, and found numerous claims for the BioMove 3000 and BioMove 5000 that are not covered by the above 510(k)s. Examples include:
- “The BioMove 3000 system . . . works by detecting the EMG signals still left in muscles . . . . This method teaches the brain to re-develop spontaneous and voluntary muscle control.”
- “The BioMove 3000 is a home device which will work in almost all standard stroke cases, except when the remaining voluntary movement of the stroke survivor is close to zero. If the patient still has voluntary movement e.g. a toe or finger, the BioMove home system is the right choice.”
- “The BioMove 5000 is not only the best Stroke Rehabilitation system in the world but also the easiest stroke therapy device for use by the stroke survivor.”
- “The BioMove 5000 is equally well suited for muscle rehabilitation therapy after Spinal Cord Injury [SCI] and Cerebral Palsy (CP).”
- “If the stroke survivor hardly has any movement left, the BioMove 5000 Pro device is the right choice as it is able to measure very weak EMG signals with its superior EMG detector and signal processing system.”
During the review of the 510(k) for the BioMove 5000 device, your firm was advised that the setting called “spinal cord injury” was not an indication under the proposed indications for use or cleared under the predicate device and that data to support the safe and effective use for specific ailments was required. In an email correspondence dated April 15, 2008, your firm agreed and revised by renaming the settings to reflect the gain levels for the device.
The promotion or labeling of these devices for use in the rehabilitation of spinal cord injury and cerebral palsy and the statements made regarding the devices’ ability to teach the brain to re-develop represent new intended uses that require a premarket notification submission under section 510(k) of the Act, 21 U.S.C. § 360(k), per 21 CFR 807.81(a)(3). Additionally, comparative claims regarding the device being the best and easiest stroke rehabilitation system in the world requires clinical data and a new 510(k) submission.
The FDA has also learned that your firm is marketing the Curatron 2000HT, Curatron 2000XP, Curatron 2000PC, and the Curatron Ultra-Power 3-D PEMF devices in the United States without marketing clearance or approval, in violation of the Act.
The Office of Compliance reviewed your firm’s website, www.curatronic.com on December 19, 2012, and found the following claims for Curatron PEMF devices:
- “a safe and non-invasive way to effectively treat acute and chronic pain as well as rheumatic disorders including arthritis, fibromyalgia, and osteoporosis.”
- “PEMF promotes healing of soft tissue injuries, inflammatory joints, delayed and non-union fractures, and improves circulation and cellular metabolism.”
- “Lack of sleep often goes hand in hand with chronic pain and may result in a vicious circle of pain preventing sleep while sleep deprivation results in worsening pain. The Curatron PEMF systems address both these issues at once by simultaneously reducing pain and improving sleep.”
The Curatron systems are bone-growth stimulators that incorporate pulsed electromagnetic field technology, resulting in them being classified as Class III devices that require PMA approval. Therefore the BioMove 3000, BioMove 5000, Curatron 2000 HT, Curatron 2000 XP, Curatron 2000PC, and Curatron Ultra-Power 3-D PEMF devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360(e)(a), or an approved application for an investigational device exemption under section 520(b) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, 21 CFR 807.81(b). .
The kind of information that your firm needs to submit in order to obtain approval or clearance for its device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html
. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
The Office of Compliance requests that Curatronic Ltd. immediately cease the dissemination of promotional materials for the BioMove 3000, BioMove 5000, Curatron 2000 HT, Curatron 2000 XP, Curatron 2000PC, and Curatron Ultra-Power 3-D PEMF devices the same as or similar to those described above. The Office of Compliance also requests that Curatronic Ltd. immediately cease distribution of the Curatron 2000HT, Curatron 2000XP, Curatron 2000PC, and Curatron Ultra-Power 3-D PEMF until clearance or approval is obtained.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps that your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your firm’s response should be sent to:
Ms. Toni Stifano
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
Silver Spring, MD 20993
Please refer to the Unique Identification Number GEN0901250 when replying. If you have any questions about the contents of this letter, please contact Ms. Stifano at (301) 796-3517.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Steven D. Silverman
Office of Compliance
Center for Devices and