Has anyone tried the BFST wrap to help heal an injury? Any feedback would be great
http://www.kingbrand.com/BFST-Home.php?REF=46PV16.258
What does your physician advise?
I canât find anything at that website that would indicate whether any formal clinical trials have been run for this therapy.
Have not tried it, but out of curiosity looked it up. It is a Class II medical device per FDAâs site listed as a âheating pad.â Class II devices do not need to undergo a clinical trial.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194438.htm
Have not had the time to do any analysis of what tech exactly it uses, but the claim is that it heats the muscle tissue directly withiout having to pre-heat the skin and fat layers.
OP: Iâd consult with the doctor if application of heat is OK.
My physician said âanything that increases the blood blowâ. He said things like ultrasound or tens (at physio), but Iâm really liking the idea that I can use this BFST treatment from the comfort of my own home and as many times as I want. It seems that would be much cheaper than physio and more beneficial if I can keep it up daily. Thank you BunsenBurner for those linksâŠthat is really helpful I like knowing it is registered. Looking more at the King Brand site, it describes also how it isnât just a heating pad, but emits electro magnetic energy to get the blood flowing deeper down below the dermal layer to get the nutrients where you need them, to be able to heal at a faster rate. Iâm also really liking the 30 return policy
Will keep you guys posted
Thanks again.
Maizie, I hope your injury heals soon!!
Even though clinical trials for this specific device arenât required, at minimum there should be a link to a verifiable reference that provides some kind of evidence for at least the theoretical basis for the therapy. I would want to know whose research measured the ability for âelectro magnetic energy to get the blood flowing deeper down below the dermal layerâ, and just exactly how much good that does. Iâd also want evidence that this device really is superior to an everyday heating pad. But then Iâve been known to read bio-science journals just for fun, so Iâm weird that way.
Happymom, it IS a heating pad. A nice looking one, indeed. No clinical trials or any studies are needed to compare one heating pad to another.
Then if it is just a nice heating pad, it the OP doesnât already have one in the closet, Iâd say stop by at CVS on the next shopping trip and pick one up there.
So someone contacted our company asking about this post. I work for King Brand and will answer your questions. I apologize if I am long in the tooth.
It is not correct that Class II medical devices do not need to undergo clinical trials. The Class II designation means only that the device is of a nature that misuse or device failure or a lack of design consideration has the potential to cause significant individual harm. This product is Class II because it actively transmits energy from the device to the patient. A Class II medical device has to meet a variety of safety requirements and design standards in order to be approved for public use. Any device that is FDA Class II has been designed to medical standards that far exceed any consumer goods standards.
There is something called 510K which allows devices to be approved based on both risk to the patient given the technology and intended use. If an existing category exists that can encompass the risks and intended uses then FDA allows âpre-approvalâ for a device to go to market without spending millions on risk studies. This reduces the cost of bringing technology to market and speeds the process. If, during their eventual investigation, FDA decided there were additional risks or failure to provide sufficient evidence that the declared results were in line with the claims they would disallow the market of the device.
It is a medical device solely because we make medical claims (Blood Flow Stimulation Therapy that accelerates healing). The fact that is a Medical Device means that the design and science are subject to FDA validation. Our facility and technology has been thoroughly inspected by FDA (and Health Canada and various ISO agencies) and these agencies have validated that we are both producing a device for which we can make these claims and that we are meeting the quality and safety standards of a Class II medical device.
There are two ways to protect your technology. One is patented technology and the other is proprietary technology. With patented technology you put all your information out to the public and lay claim that only you can do this. The issue is that it provides a road map for companies to copy what youâve done and then try to make small tweaks to get around your patent. If this happens youâve basically educated your competition and wasted a ton of money. With proprietary technology itâs about keeping what you do a Trade Secret. This is a secret from the general public and your competition. It IS NOT a secret in regards to FDA and ISO auditors and bodies that must know the information in order to do their job. These parties are bound by non-disclosure that should stop the technology from leaking to the public but gives them all the access/info they require to properly evaluate the product in the public interest.
I wish that everyone understood the significance of being an FDA Class II medical device and what it means to the consumer. First, just because you buy something at CVS or Walgreens does NOT mean it is a medical device. In fact, most devices sold in chain store pharmacies are actually consumer goods. This means that there are NO requirements to prove anything and almost no safety requirements and FDA has never even considered them. Just because you buy it at a pharmacy doesnât mean it is a medical product. They mislead you in this regard. Iâll spare you the details but there are levels of safety for materials from dangerous to safe - none, infrequent contact, outer ware, close to body, infant use, and hospital grade (ISO10993). A regular heating pad doesnât have to meet any of these. A medical heating pad may get by on âinfrequent contactâ. Our product is hospital grade (safer than diapers and baby clothes). Even buying medical devices does not guarantee quality. Look at these records from the FDA to see how âheating padsâ that are sold as medical devices have injured and killed people. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/results.cfm?start_search=41&searchyear=&productcode=&productproblem=&devicename=IRT&modelNumber=&reportNumber=&manufacturer=&brandname=&eventtype=&reportdatefrom=06%2F01%2F2015&reportdateto=08%2F31%2F2015&pagenum=10
In terms of King Brand products, our products are incredibly safe (hospital ICU safe) and our claims are honest and have been checked for accurracy. You can call it a heating pad or a microwave oven or toaster or ultrasound on steroids or a ray gun if you like. At the end of the day it does what is claimed and it is very safe to use. The FDA really does work hard to get us safe and effective medical treatment.
^^No one is doubting that it is safe. Thatâs why it is a Class II device listed by the FDA. Do no harm to the consumer - this is what the FDAâs main concern with Class II devices. But posters are not questioning the safety. Do you have any peer review journal references of any âclinical studiesâ confirming the claimed superiority of the pads compared to regular heating pads for @happymomof1 ? It would be nice for you to have a few links on your site to the PubMed abstracts.
âYou can call it a heating pad or a microwave oven or toaster or ultrasound on steroids or a ray gun if you like.â
Different parts of the electromagnetic spectrum. Got it. There is another reason people might choose to keep something a trade secret: there is too much prior art for it to be patentable.
Yup. @KBScienceGuy There is no link at all to any article (let alone one in PubMed) that indicates that this kind of device does what the website claims it does. Please give us one link to an article published in a peer-reviewed and preferably English-language journal that clearly indicates that somewhere sometime someone did a study that showed that heat applied for X minutes Y times a day for injury type Z at a temperature of W degrees F or C for N days produced superior healing when compared to an alternative treatment, placebo, or no-treatment control. Heck, weâll accept a peer-reviewed article not in English provided there is an English language abstract. The article doesnât have to include specifics from your companyâs proprietary research. Research that is relevant to the device will be good enough. And it would be really cool if this could be an open access article so we donât have to nag our lab rat buddies to do us the favor of tracking it down and forwarding us the PDF.
UmmmâŠadvertisement.?
No, I would not call it an ad. The thread was started by a CC poster asking a question about the product she wanted to use. Some companies monitor the web for buzz about their products. In the past, we had folks from companies (TurboTax?) come to CC and answer some questions.
Oh, by the way⊠A side note⊠Patented does not mean it is actually effective! The utility standard at the patent offices does not rise to the level of the FDA requirements.
Thanks everyone for their feedback and opinions. Much appreciated.
Well just an update in case anyone was interestedâŠI bought the BFST for my foot (plantar fasciitis and metatarsalgia) and within a month and a half of treatments, I am no longer limping!! Yah. I did cold therapy too and taped my foot, and just canât believe it. I limped around for 8 months! I just wanted to share in case anyone feels as hopeless as I did about treatments and doctors.
I have been suffering with PF for close to 6 months. I have tried many things, and am now waiting on my custom orthotics. Itâs good to hear you have improved so much
Thanks ije62 I donât think people understand how difficult an injury at the bottom of your foot can be. Iâm wishing you all the best. One tipâŠrest your foot on a cold compress every time after being on your feet for a while. Most of that pain is from the fascia being so inflamed after being on it. Good luck