Regulatory Status and Intended Use
E-Stim Systems Ltd designs and manufactures adult novelty products for consensual sexual pleasure between adults. Our products are not medical devices.
Statement of intended use
Every product we make, sell, ship or advertise is intended solely for adult sexual pleasure. We make no medical, therapeutic, clinical, diagnostic or rehabilitative claim for any product in our range, in any market, through any channel. Our products are not intended to diagnose, treat, cure, mitigate or prevent any disease or condition.
Why FDA clearance does not apply
The US Food and Drug Administration regulates products on the basis of intended use, not physical form. A device intended for a medical purpose, such as pain relief, muscle rehabilitation, treatment of sexual dysfunction or pelvic floor therapy, falls within its remit. An adult novelty product sold for sexual pleasure does not.
Per Section 201(h)(1) of the Food, Drug, and Cosmetic Act, a device is:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- (A) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).
There is no FDA approval, clearance or registration pathway for adult novelty products, because the FDA does not classify them as devices. No manufacturer of adult novelty products holds FDA clearance for them. The document does not exist to be issued.
What our products are not
- Not sold, labelled, packaged or marketed for pain relief, physiotherapy or rehabilitation
- Not intended for use under medical supervision
- Not supplied to hospitals, clinics or practitioners as clinical equipment
- Not intended for use by anyone under 18
What they are
Precision electrodes and power units, CNC-machined at our workshops in Watford, England, since 2004. They are sold to adults for consensual electro-stimulation play. That is their only intended use.
A note on our safety guidance
Our documentation asks customers with pacemakers, implanted electronic devices, heart conditions or epilepsy not to use our products, and advises against use above the waist. These are precautionary exclusions written to keep customers safe. They are not medical claims and they do not indicate a therapeutic purpose. Any responsible manufacturer of an electrical product would publish the same.
For customs officers, brokers and importers
This statement applies to the entire E-Stim Systems range, including power units, electrodes, cables, sounds and compression products. Written confirmation for a specific shipment, product or commodity code is available on request.
