profile

Bathmate's Tim Brown Talks Legal Standards of Penis Pump Production

Bathmate's Tim Brown Talks Legal Standards of Penis Pump Production

Like most products claiming to increase penis size, penis pumps have long been viewed as part of the gimmicky, novelty side of the pleasure products space. The Brits at Bathmate, however, find this dismissive attitude about as laughable as a bachelor party blow-up doll — and possibly even downright irresponsible.

Since the company’s inception in 2006, Bathmate has delivered myriad iterations of the brand’s namesake: a hydrotherapy pump utilizing warm water and suction to take advantage of the penis’s naturally hydraulic erectile function.

At Bathmate, regulatory compliance is a full-time job.

Founder John Oakes, a mechanical engineer, developed the Bathmate penis pump to operate as, to quote the company’s training script, “a gym workout for your penis.” For men with erectile dysfunction or a simple desire for more length and girth, the Bathmate promises results with daily use, just like any other physical exercise routine.

Bathmate contends that it has maintained high standards from the beginning. However, the company is now arguing for standardized regulation of penis enlargement products.

Tim Brown, global brand manager for Bathmate, says the company’s water-powered penis pumps — and all penis pumps, for that matter — technically fall into a product category above and beyond adult novelty: medical devices. That is because they “affect the structure or any function of the body,” as FDA regulations specify for inclusion in that category.

“They are commonly used to treat erectile dysfunction,” explains Brown, who leads global sales and compliance at Bathmate. “More specifically, penis pumps are what the FDA calls ‘external penile rigidity devices,’ as they are used to create or maintain an erection for sexual intercourse. The FDA says constriction rings that restrict venous blood flow leaving the penis during sex are also external penile rigidity devices.”

Brown clarifies that since penis pumps and constriction rings present certain risks to consumers, ranging from injury due to deficient design to aggravation of existing medical conditions by misuse, the FDA classifies these products as Class II medical devices. Therefore, companies that manufacture and sell penis pumps and construction rings must follow FDA design and manufacturing specifications and labeling requirements, to ensure safe and effective products.

“We want to stand out above the competition,” acknowledges Brown. “There are so many other pumps on the market. We feel if you are going to put your penis anywhere, it should be well looked after and safe, which is the reason we go the extra mile.”

In case Bathmate’s B2B partners think the company’s recent advocacy in this area means that it has only just begun to follow medical device regulations, Brown clarifies, the opposite is true.

“There’s nothing new about Bathmate quality or standards,” states Brown. “We have always manufactured to a high standard and have the accolades and certification to prove it. However, we are always looking at better ways to manufacture our products, so occasionally the production process does change to improve the products and be more environmentally friendly.”

Brown adds that Bathmate has been an FDA-registered establishment for years, with every single product appropriately listed in the FDA’s database, and that the company also holds International Organization for Standardization (ISO) certification for the brand’s medical device quality management system and manufacturing processes. He also emphasizes that the company’s U.K. manufacturing facility is routinely inspected for quality control and assurance systems, pressure testing, the traceability of individual parts and completed product assemblies, and even customer-facing policies.

“These intensive week-long inspections make us a better company, and when coupled with a superior product, set us apart from the rest,” says Brown.

As usual, navigating through red tape doesn’t come cheap. Meeting compliance obligations is a pricey way of doing business, but one that Bathmate sees as well worth the cost.

“At Bathmate, regulatory compliance is a full-time job,” Brown affirms. “Really! We have retained two outside FDA consulting firms and we even have one employee whose entire job is dedicated to implementing our compliance program.”

Fortunately, Brown says, meeting the highest standards on one continent makes it easier to comply with the rest of the world’s regulations.

“The U.S. has generally stricter standards,” explains Brown. “So if our products are compliant with U.S. law, then they generally comply globally or they require minimum changes.”

In the end, Brown notes, the whole point of understanding and complying with governmental legalese is consumer safety and product efficacy.

“This is actually the most important part of FDA registration,” says Brown. “It ensures that these medical devices incorporate design features that mitigate risk of injury and are safe and effective when used as directed.”

Brown advises any penis pump manufacturing outfit that can’t answer a few questions from the FDA to get schooled and shape up before they come knocking. Those involved in the design and manufacturing process, he points out, need to understand complex anatomical and engineering knowledge, such as the safety limit for a body under pressure, the pressure created by the pumps a company manufactures or imports and what happens to the body when safe pressure limits are exceeded. Brown hopes to rally the industry around caring for consumers.

“I think we can all agree that registering with the FDA and manufacturing safe and effective products that are fully traceable is a goal every company should aspire to,” Brown says. “Perhaps that’s one of the reasons why Bathmate pumps are the highest-quality penis pumps in the world,” he concludes with a grin.

Copyright © 2025 Adnet Media. All Rights Reserved. XBIZ is a trademark of Adnet Media.
Reproduction in whole or in part in any form or medium without express written permission is prohibited.

More Articles

opinion

A Guide to Having a Successful Adult Retail Trade Show Experience

Pleasure industry trade shows offer a vital platform for showcasing the latest toys and other products, building connections with potential buyers and generating industry buzz. However, simply attending isn’t enough — you need a strategic plan to stand out from the crowd.

Vincent Renou ·
opinion

Pleasure Brand Marketing and PR Trends to Watch in 2025

From the lockdown boom to the economic pressures of a post-pandemic world, we have seen shifting technologies, evolving consumer expectations and a hunger for authenticity shape pleasure product marketing and public relations.

Scarlett Ward ·
profile

WIA: Jennifer Jolicoeur Reflects on Passionate Home Party Journey

Nearly 30 years ago, Jennifer Jolicoeur became the first adult toy party planner in Rhode Island. She gained experience with another company before launching Athena’s Home Novelties from her apartment in 1998, with the mantra “Educate. Empower. Entertain.”

Women In Adult ·
opinion

Tips for Embracing Diversity Through Language

We are all used to slang terms shifting from generation to generation, as words or phrases get co-opted and acquire new meanings. It is a much rarer occurrence when some of the most fundamental words in our language undergo a major transition in a short space of time, but that is exactly what is happening right now with pronouns.

Claire Sass ·
opinion

A Look at the Ethics, Risks of AI-Generated Sexual Wellness Content

Few technological advancements have inspired the level of controversy that has been generated by the advent of artificial intelligence, which is now powering or being incorporated into digital tools we use every day.

Anne Hodder-Shipp ·
opinion

How the 10-Minute Delivery Model Is Disrupting the Indian Market

In September, when the iPhone 16 was released, a person in India had the brand-new model delivered to him — while he was waiting in line at an Apple Store, before reaching the front for his turn. How? By ordering on Zepto, one of the leading “quick commerce” platforms that are changing how consumers shop in India.

Raj Armani ·
opinion

How to Keep Meta From Derailing Your Social Media Campaign

The heavy hand of Meta can be both unforgiving and unpredictable. Profiles that Meta decides have violated its platforms’ terms may find themselves on the receiving end of punishments — including the dreaded “shadow ban,” which can be damaging for a brand’s social media campaign and strategy.

Scarlett Ward ·
trends

Pleasure Biz Mainstays Reflect on Decades-Long Careers, Share Advice for Up-and-Comers

“If you do what you love, you’ll never work a day in your life.” That saying definitely holds true in the pleasure industry, where many executives build careers that exceed a quarter century.

profile

WIA Profile: Melissa Fite

Though she works behind the scenes, Melissa Fite has a bird’s-eye view of the pleasure products industry. As the marketing coordinator and junior graphic designer at XR Brands, Fite gets an intriguing overview of the latest consumer trends, plus an exciting sneak peek at XR’s newest sex toys before they hit the shelves.

Women In Adult ·
profile

Distribuciones-BES Spreads Pleasure Brands' Reach Across Mexico

It’s time to brush up on your Spanish, sex toy manufacturers. The Mexican market is thriving, and the country’s distribution and retail businesses are eager to forge new connections with brands from around the world.

Colleen Godin ·
Show More