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WARNING LETTER

Pelvic Therapies, Inc MARCS-CMS 518409 —


Delivery Method:
Hand Delivery

Recipient:
Recipient Name
Elizabeth Janapol
Pelvic Therapies, Inc

390 Oak Ave., Suite G

Carlsbad, CA 92008
United States

Issuing Office:
Los Angeles District Office

United States


 

  

Black HHS-Blue FDA Logo

 

Office of Medical Device and Radiological Health Operations
Division 3 West
19701 Fairchild Road
Irvine, CA 92612 

 
 

WARNING LETTER

VIA HAND DELIVERY

October 17, 2017

WL# 518409-18

Elizabeth Janapol, Owner
Pelvic Therapies, Inc.
390 Oak Ave., Suite G
Carlsbad, CA 92008

Dear Ms. Janapol:

The United States Food and Drug Administration (FDA) has learned that your firm, Pelvic Therapies, Inc., located in Carlsbad, California, distributes and promotes the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V products 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 Federal Food, Drug, and Cosmetic Act (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 the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.

FDA has reviewed the marketing claims and materials shown on your websites; www.thera-wand.com, www.pelvictherapies.com, and Amazon’s website, www.amazon.com/s/ref=nb_sb_noss_1?url=search-alias%3Daps&field-keywords=therawand, and determined that the devices, the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V, 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. § 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). These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k), 21 U.S.C. § 360(k).

Specifically, your firm is marketing the PelviWand-LA and PelviWand-V on the websites; www.pelvictherapies.com and www.amazon.com/s/ref=nb_sb_noss_1?url=search-alias%3Daps&field-keywords=therawand for intended uses including: 

• Pelvic floor muscle dysfunction (i.e., pain over activity, shortening, trigger points)
• Vaginismus
• IBS, Chronic Constipation, Crohn’s Disease
• Tight vaginal opening
• Sexual and rectal pain
• Vaginal atrophy from natural aging and early menopause
• Spinal, sacroiliac, and hip joint issues
• Endometriosis, uterine fibroids, ovarian cyst
• Non-bacterial Prostatitis and Chronic Pelvic Pain Syndrome
• Urological disorders such as Interstitial Cystitis

Also your firm is marketing the Premium TheraWand and Essential TheraWand on www.thera-wand.com/ for the intended uses including: 

• Treatment of post-surgical scar tissue that can sometimes entrap nerves and cause pain
• Endometriosis, uterine fibroids, ovarian cyst
• Urological disorders such as Interstitial Cystitis
• Vaginal atrophy from natural aging and early menopause
• Pelvic Floor trauma from abuse
• IBS, Chronic Constipation, Crohn’s Disease 

Your firm promotes the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V devices with intended uses that have not been evaluated by the FDA and require a premarket submission in order to evaluate the devices’ safety and effectiveness. The use of these devices for the intended uses specified above may increase the risk of injuries to patients.

On October 20, 2016, the Center for Devices and Radiological Health mailed your firm an FDA correspondence requesting your firm to provide the FDA the clearance number for the Essential TheraWand and Premium TheraWand or, if you do not believe that you are required to obtain FDA clearance for the Essential TheraWand and Premium TheraWand, to please provide us with the basis for that determination. While your firm initially responded to our letter, your firm has not responded to further attempts to contact you. Additionally, on December 9, 2016, Los Angeles District Office attempted a “for-cause” inspection of your firm and was refused entry.

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 to obtain approval or clearance for your device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm#step2. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

Also, under section 510 of the Act, 21 U.S.C. § 360, manufacturers of medical devices are required to register with the FDA annually. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal year 2017.

Therefore, all your firm's devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).

Our office requests that Pelvic Therapies, Inc. immediately cease activities that result in the misbranding or adulteration of the Essential TheraWand, Premium TheraWand, PelviWand-LA and PelviWand-V such as the commercial distribution of the devices for the uses discussed above. Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 (15) business days from the date you receive this letter, of the specific steps 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 (which must address systemic problems) 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:

US Food and Drug Administration
Division 3/West
Office of Medical Device and Radiological Health Operations
19701 Fairchild
Irvine, CA 92612-2506

Refer to the identification number [FEI #3013059931] when replying. We remind you that only written communication is considered as official. If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or raymond.brullo@fda.hhs.gov.

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. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. 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.
 

Sincerely,
/S/

Shari J. Shambaugh
Acting Program Division Director
 

Cc:
David M. Mazzera, Ph.D., Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
 

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