Industries · Health and wellness
Heated caps, UV-C holders, home beauty devices and smart bottles touch skin, water and daily routines. We take them from idea to factory: industrial design, electronics and firmware, safe heat and light, wording that stays on the right side of wellness rules, and manufacturing with our partner factories in China and Pakistan.
The short answer
Wellness device development turns an idea for a health, comfort or beauty product into one people can safely use at home. It covers a design that is comfortable on skin, heat and light kept within safe limits, electronics and firmware, the safety standards for household or home-medical use, claims that match the product’s route, and manufacturing at a price buyers will pay.
Where wellness projects go wrong
Wellness copy drifts into medical claims.
We design to the claim you plan to make.
All projects, under NDAWarm surfaces can burn skin over long contact.
We set surface limits and add thermal cut-offs.
Heat & Cool Cap, under NDASkin, water and drink contact need safe parts.
We choose materials for each contact surface.
VitaSip, under NDAThe wrong standard wastes a test budget.
We map IEC 60335 or 60601 before the build.
UV-C Toothbrush Holder, under NDAWellness or medical?
Pick a claim to see which route it puts your product on.
“Helps you relax after a long day” Relaxation is a wellness claim. No clearance needed.
Wellness route
Medical route
We help you choose the route before design starts, because changing the claim later can mean redesigning the product.
What we build
Thermal
Our projects
Heat & Cool Cap, Smart Heating Device (our projects)
What matters most
Even heat, a safe surface temperature and comfort.
Standards we design for
IEC 60335-2-17, UL 130, UN 38.3, FDA wellness
Hygiene
Our projects
UV-C Toothbrush Holder, Smart Body Dryer (our projects)
What matters most
UV-C kept inside, warm airflow and water safety.
Standards we design for
IEC 62471, IEC 60335-2-23, EPA FIFRA, IP rating
Beauty
Our projects
RF skin device (our project)
What matters most
Contact sensing, skin-temperature limits and the right route.
Standards we design for
IEC 60335-2-115, IEC 60601-1-11, FDA 510(k)
Daily
Our projects
VitaSip smart water bottle (our project)
What matters most
Food-safe materials, a sealed base and battery life.
Standards we design for
Food contact, Bluetooth, UN 38.3, IP rating
Certification
FDA general wellness policy
What it covers
Where wellness claims end and medical ones begin.
What we do
We keep wording to wellness unless you clear it.
ISO 13485 quality system
What it covers
Quality system for medical device design.
What we do
We run medical work under our certified system.
IEC 60601-1-11 home healthcare
What it covers
Safety of medical equipment used at home.
What we do
We design for lay users, water and home power.
IEC 60335-2-17 heating appliances
What it covers
Safety of heating pads, wraps and caps.
What we do
We cap surface heat and add thermal cut-outs.
IEC 60335-2-115 skin-care appliances
What it covers
Household beauty devices that heat skin.
What we do
We limit RF output and skin temperature by design.
IEC 62471 photobiological safety
What it covers
Eye and skin safety of UV and LED light.
What we do
We shield UV-C so no light escapes in use.
EPA rules for pesticide devices
What it covers
US rules for UV devices that claim to kill germs.
What we do
We size the UV-C dose so claims can be tested.
Accredited labs, notified bodies and the FDA decide. We design to pass and prepare test-ready samples.
Our own work
Heat & Cool Cap Under NDA
A head-worn cap that warms or cools on demand.
Smart Heating Device Under NDA
A compact heater for personal warmth at home.
UV-C Toothbrush Holder Under NDA
A closed holder that shines UV-C on stored brushes.
Smart Body Dryer Under NDA
A hands-free dryer that dries you with warm air.
RF skin device Under NDA
A handheld home beauty device that uses RF energy.
VitaSip Under NDA
A smart water bottle that reminds you to drink.
Projects are under NDA, so we show what we built, not who for.
How it runs
Services we use
everything has exceeded my expectations for the development of my product.
Their team delivered top-notch electronic product development expertise, exceeding my expectations.
FAQ
The claim decides it. The FDA treats low-risk products that support general health, such as relaxation, sleep or fitness, as wellness products if they never mention a disease. Claims to treat, relieve or diagnose make it a medical device.
Usually not, if it is sold for warmth or comfort. Heating pads sold for medical purposes are Class II devices, and cooling caps for chemotherapy hair loss need a prescription. Avoid pain, migraine or hair-loss claims, and design to IEC 60335-2-17.
Rarely, if it makes wrinkle or firming claims. Over-the-counter RF wrinkle devices are FDA Class II and need a 510(k). Outside the US, IEC 60335-2-115 covers household devices that heat skin, and the EU may apply its medical device rules.
Only with test data from your own device. In the US, a germ-kill claim makes a UV light a "pesticide device" under EPA rules, and every claim needs data. "EPA approved" is never correct.
No. "Cleared" means the FDA accepted a 510(k) showing the device matches one already on the market. "Approved" is the stricter route for high-risk devices. Wellness products are neither.
Yes. Inventornest is ISO 13485 and ISO 9001 certified, so medical projects run with design controls and a risk file from the first stage. Accredited labs test, and you submit to the FDA or a notified body.
It depends on heat, radios, contact materials and whether it is a medical device. We start with a feasibility study at $1,000 to $2,000, then give you a fixed price for each stage.
Related guides
Free product call
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