| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human ServicesJAN 21 2011
WARNING LETTER
Via United Parcel Service
President/CEO
Inno-Health Technology, Co., Ltd.
8F-2, No. 61, Kung Yi Road Sect. 2,
Taichung, Taiwan 407, Republic of China
RE: Electro-Acupuncture; ACULIFE
Refer to CON1014902
Dear Sir/Madam:
The Food and Drug Administration (FDA) has learned that your firm is marketing the Electro-Acupuncture ACULIFE device in the United States (U.S.) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed your website at www.aculife-inno.com for the ACULIFE device on November 1, 2010. The product is a device within the meaning of section 201 (h) of the Act, 21 U.S.C. § 321 (h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.
The ACULIFE device was cleared in 510(k) K09193 for the following indications, "as an ELECTRO-ACUPUNCTURE device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. The ACULIFE is intended for the stimulation at hands of patient." However, your website states that by "using long magnetic wave stimulate our hand and ear acupoints [sic], Aculife can improve our blood-circulation, speed up the metabolism, and enhance circulate [sic]capability to prevent various diseases. In addition, Aculife also act [sic] as a soft massage, it is [sic]not only improves our blood circulation but also let out [sic] body recover from fatigue." Your website also lists the following as the primary functions of the Aculife device. "Promoting Blood Circulation: Magnetic waves to stimulate acupoints to promote blood circulation achieving the same as traditional acupuncture; Magnetism Effect:
Magnetic waves to magnetize body fluids and increase the body fluids and increase the body's immunity against diseases; Health: Enhanced immunity which effectively prevents illnesses or disease as one of the primary functions of the Aculife; Dual Relieve Methods: Be in total control of your health. 'Palm Acupoints Combi' or the 'Ear Acupoints Combi' can be effected separately or in combination; Easy to Operate: Device is suitable for the whole family as it is easy and safe to use."
These statements represent a major change or modification in the intended use of your device that requires a new premarket notification. 21 CFR 807.81 (a)(3)(ii). Therefore, the ACULIFE device is adulterated under section 510(f)(1)(B) of the Act, 21 U.S.C.C 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) 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 you did not notify the agency of your intent to introduce the devices into commercial distribution for the intended uses discussed above, 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 C.F.R. 807.81 (b). The kind of information you need to submit in order to obtain approval or clearance for your device is described at http://www.fda.gov/cdrh/deviceadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
In addition, your sale of the product through distributors who sell your products to consumers, as well as your promotional claim that states that the device is easy to operate and is therefore suitable for use by the whole family, implies that patients can be their own acupuncturist. This implies over the counter use, which is not a part of your cleared premarket notification.
The ACULIFE device is also misbranded under 501 (a) of the Act (21 U.S.C. §352(a)) in that the labeling for the device at www.aculife-inno.com contains statements, and the FDA logo, which represent or suggest that the device has been approved by FDA for uses listed on your website, which is false.
The Office of Compliance requests that Inno-Health Technology immediately cease marketing the ACULIFE device for unapproved uses such as those described above. You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. Such action includes, but is not limited to seizure, injunction, and/or civil money penalties. Your device is also subject to refusal of admission under section 801 (a) of the Act, 21 U.S.C. §381 (a), in that it appears to be adulterated and misbranded. As a result, FDA may issue an Import Alert, whereby FDA may detain your devices without physical examination upon entry into the United States until the corrections are completed.
U.S. federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Government will not be granted until the violations related to the subject device are corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations from occurring again. Include documentation of the corrective actions you have taken. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.
Your response should be sent to:
Terri T. Garvin
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
10903 New Hampshire Avenue
WO66-3521
Silver Spring, MD 20993
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations by your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt steps to correct the violations and to bring your products into compliance.
Sincerely,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
No comments:
Post a Comment