Applicability of 60601 vs. 60335

[suffusive]

I have a client that wants to release a hand-held massager with a heating function. Currently they make "muscle scrapers" and they want to expand their product line. They market their products to the cross-fit community for "muscle recovery" and muscle soreness and these are explicitly intended solely for home use by consumers (not medical professionals or medical environments).

The US and Canada explicitly regulate hand-held massagers as medical devices. This makes sense because there's really no such thing, beyond an erotic vibrator, that classifies as a "hand-held massager" which doesn't intend to sooth muscle aches and soreness. My confusion isn't about the regulation it's around the test requirements.

Because they're medical devices in many jurisdictions everyone keeps saying that they should test to IEC 60601. But there's a standard for massagers, IEC 60335-2-32, which explicitly covers:

– foot massagers;
– water filled foot massagers;
– hand-held massagers;
– massage beds;
– massage belts;
– massage chairs;
– massage pads

Moreover, the Scope of this document does NOT explicitly exclude "appliances for medical purposes (IEC 60601)" like the normative 60335-1 standard. To me that's because, as mentioned, at some level basically all massagers are intended for soreness which makes them implicitly medical.

There is no 60601 series standard for massagers which complicates this tremendously. But there is for a similarly-intentioned device: heating pads (60601-2-35). Interestingly, in the scope of that document it explicitly excludes "Heating devices intended for physiotherapy"--so basically if you're using a heating pad at home for muscle aches and soreness then 60601 doesn't apply and presumably the 60335-2-17 does instead. The home-based 2-17 excludes "appliances specifically intended for use under medical supervision" which makes sense. I feel like this langauge would also be in the massager 2-35 standard if there was a similar version in the 60601 series.

So, why wouldn't a regulatory authority accept testing to 60335-2-35? The FDA will accept the very similar UL 1647, but I'm not sure about the EU or Canada which are both intended markets.

Any thoughts or comments are greatly appreciated,
~Josh

 

[Peter Selvey]

The applicability of a regulation is decided not on the name of the device (e.g. "massager") but the intended purpose as stated in the instructions for use and marketing material. So you can have an identical massager but in one the manual says "for relaxation and rejuvenation" which is not medical and another which is "for pain relief" or to "speed up recovery from muscle tear" which are medical.

So could have a three scenarios:
Manufacturer A: does not want to apply medical device regulations, and takes great care to avoid mentioning any specific medical treatments for the device.

Manufacturer B: does not want to apply medical device regulations, but is lazy and wants to sell more so includes all sorts of weird and wonderful claims (e.g. cures arthritis) many of which could reasonably be considered medical but are unsupported. That's illegal, by the way.

Manufacturer C: does want the device to be medical, makes specific claims and backs them up with clinical literature or clinical evidence.

So ... that's the regulatory side. And the FDA is sure to follow this as well.

For the standards, if it is non-medical then it the IEC 60335 series is fine.

If it is medical, technically IEC 60601-1 applies but there could be arguments for using IEC 60335-2-35 if this fits better. As an experienced user of IEC 60601-1, there's a lot of stuff in there that doesn't really make sense for a home use massager and I would suspect that the 335 would actually be more effective in addressing the safety issues specific to massagers, in particular the mechanical aspects.

 

[AmyBaxterMD]

It's very frustrating. We have all the patents for pain and medical indications for non-hand held vibrating devices with thermal co-application, and are FDA 510K cleared for vibration and heat/ice devices. However, CMS explicitly doesn't cover "comfort items" which to them is any massager. So while I'd love to use IEC 60335-2-35, my argument that we're mechanical stimulation not massage is undermined.