Key takeaways
- Emsella is BTL's FDA-cleared (not approved) pelvic-floor chair for urinary incontinence.
- It is not cleared for vaginal tightening, sexual function or "vaginal rejuvenation".
- BTL's typical course is six sessions, twice a week; practices set their own plans.
- Published evidence is mostly small studies without a sham control group.
- No independent national price was confirmed, so compare written quotes for the full course.
What is Emsella?
Emsella is the name BTL, a medical-device company, gives its pelvic-floor chair.
FDA cleared BTL's pelvic-floor chair — model HPM-6000U, 510(k) K162010 — on December 13, 2016, as a non-implanted electrical continence device intended for electromagnetic stimulation of the pelvic floor to treat urinary incontinence in women.
A later version, model HPM-6000UF, was cleared in 2018 for male and female urinary incontinence.
BTL markets the chair under the Emsella name.
BTL's pelvic-floor chair clearances
| Model | 510(k) | Cleared | Cleared use |
|---|---|---|---|
| HPM-6000U | K162010 | December 13, 2016 | Urinary incontinence in women |
| HPM-6000UF | K181497 | 2018 | Male and female urinary incontinence |
One caution on names: FDA's 510(k) documents list model numbers, not brand names.
The match between the cleared models and the Emsella name is inferred from BTL being the applicant, the device type and the timing — we could not find an FDA document that names Emsella, and BTL's own US site does not cite the K-numbers.
The cleared intended use for the 2018 version, in the FDA record's words, is "entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence." In plain terms, the device works on muscle: you sit on the chair while it delivers electromagnetic stimulation to the pelvic-floor muscles.
BTL also makes the Emsculpt body-contouring line, which the company built on the electromagnetic muscle stimulation it brands HIFEM.
The pelvic-floor chair is the same idea aimed at a different muscle group: the cleared use for this chair is the pelvic floor, not the abdomen or buttocks.
Emsella is a cleared device: it went through FDA's 510(k) clearance pathway for medical devices. "FDA-approved" is the standard for drugs and injectables, not for this chair — a distinction worth keeping in mind when you read marketing copy.
Who does Emsella help?
The cleared use is urinary incontinence — first in women under the 2016 clearance, and, from the 2018 version on, in men and women alike.
The language of that clearance is about muscle function: rehabilitating weak pelvic muscles and restoring neuromuscular control.
FDA's records for the device list prescription use.
The published study this page draws on enrolled 35 women with stress or mixed incontinence.
Whether the chair fits your own situation, and whether your symptoms fall inside the cleared use, is a question for a licensed provider who has examined you.
What the clearance does not cover matters just as much.
Emsella is not cleared for vaginal tightening, sexual function or the bundle of treatments marketed as vaginal rejuvenation.
In July 2018, FDA warned that lasers and other energy-based devices marketed for "vaginal rejuvenation" have serious risks and lack adequate evidence, and said it had not cleared or approved any device for those uses.
That same month, FDA sent letters about inappropriate "vaginal rejuvenation" marketing to seven device makers — BTL Industries, Emsella's maker, was one of them.
The letters were about marketing claims, not findings of wrongdoing.
If a practice offers the Emsella chair for "vaginal tightening", sexual function or menopause symptoms, that is not the cleared use. FDA's 2018 statement said no device had been cleared or approved for the "vaginal rejuvenation" uses being marketed, and warned that the marketing had serious risks and lacked adequate evidence.
How many Emsella sessions do you need?
BTL's published protocol is the benchmark this page uses.
The company says each session lasts about half an hour — 28 minutes in its own wording — and that a typical course is six sessions, scheduled twice a week.
Those are the manufacturer's figures, not a medical rule.
BTL's site describes a "typical" course; individual practices set their own plans, and your provider's schedule may differ.
If a practice's plan is much longer or more expensive than the six-session benchmark, it is fair to ask why.
BTL also says you can get back to your daily routine right after a session and describes the treatment as needing no recovery time.
That is the manufacturer's description.
Ask your provider what they tell their own patients about the hours after a session.
Find Emsella providers near you
Compare Google ratings, reviews and posted prices at med spas in your city.
How much does Emsella cost?
We could not confirm an independent national price for Emsella from the sources reviewed for this guide, so you will find no dollar figure here.
The honest way to compare practices is in writing, for the full course.
The structure to ask about follows from the protocol: BTL's typical course is six sessions, so the number that matters is what the whole course costs, not one session.
Ask each practice whether it prices the chair per session or as a course package, what the total comes to, and what it charges if you stop before the course ends.
When quotes differ, the structural things to put side by side are how many sessions the provider sets, what the visit includes, and whether the practice bundles the chair with other services.
No national figure covers any of that in the sources we reviewed — which is why a written, line-by-line quote beats an average.
Ask three practices the same four things: the total for the full course your plan needs, the single-session price, what a visit includes, and the practice's policy if you stop after a few sessions. Written answers are comparable; verbal ones drift.
What does the evidence show?
Evidence for Emsella is mostly small uncontrolled studies.
A recent example is a 2024 study of 35 women with stress or mixed incontinence, published in Therapeutics and Clinical Risk Management, in which each participant took a six-session course.
Their scores on the ICIQ-SF incontinence questionnaire fell from 10.2 at baseline to 5.3 after the six sessions, and stood at 4.3 at the one-month follow-up.
Average ICIQ-SF score (lower means fewer symptoms)
35 women with stress or mixed incontinence, six-session course
Source: 2024 single-arm study, Therapeutics and Clinical Risk Management; no sham control group
Two limits matter when you read those numbers.
First, the study had no sham control group: without a placebo-style comparison, it cannot show how much of the change came from the chair rather than from other factors.
Second, the follow-up ran one month, so this study says nothing about where scores settle a year later.
BTL publishes its own improvement and pad-use figures in its marketing materials.
Those are the manufacturer's numbers, not the peer-reviewed results described above, and this page keeps the two apart.
Peer-reviewed study
- 35 women, six sessions
- Questionnaire scores, group averages
- No sham control group
- One-month follow-up
BTL's marketing figures
- Published by the manufacturer
- Improvement and pad-use figures
- Not the peer-reviewed results above
A note on averages: the study figures above are group averages for 35 women, not a prediction for any one person.
Ask a licensed provider what an evidence base this small and this recent would mean for your case.
How to find Emsella near you
When you see the chair advertised under the Emsella name, the questions below apply anywhere.
FDA's records for the device list prescription use.
One of the first things to establish at any practice, then, is who oversees the plan: you want a licensed clinician assessing you, setting the number of sessions and reviewing how they are going.
- Ask what the FDA clearance for the chair covers — for this device, it is urinary incontinence
- Ask who assesses you and oversees the plan; the device is listed for prescription use
- Ask how many sessions are in your plan and how they are scheduled
- Ask for the full course price in writing, and the single-session price alongside it
- Ask what follow-up looks like once the course ends
Our med spa checklist covers the wider questions — credentials, supervision, red flags — that apply to any treatment you book.
Whoever you see, the same rule holds: this chair is a cleared treatment for urinary incontinence, and a use beyond that is not the use FDA cleared.
Frequently asked questions
Is the Emsella chair FDA-cleared?
Cleared, through the 510(k) device pathway.
FDA cleared BTL's pelvic-floor chair in December 2016 for urinary incontinence in women, and a 2018 version for male and female urinary incontinence.
This chair is cleared, not approved — clearance and approval are different FDA pathways.
The clearance covers electromagnetic stimulation of the pelvic floor; it does not cover vaginal tightening, sexual function or "vaginal rejuvenation".
Does the Emsella chair really work?
The honest answer is that published evidence is limited.
A 2024 study of 35 women with stress or mixed incontinence reported symptom-questionnaire scores falling from 10.2 to 5.3 after six sessions, and 4.3 at one month — but it had no sham control group, and evidence for Emsella is mostly small uncontrolled studies.
BTL's marketing materials cite improvement and pad-use figures of their own.
Ask a licensed provider what this evidence would mean for your case.
How much does Emsella cost?
We could not confirm an independent national price for Emsella from the sources reviewed for this guide.
Because BTL's typical protocol is six sessions, the number to compare is the full course, not one session: ask each practice what the complete plan costs, what a single session costs alone, and what happens if you stop early.
Can men use the Emsella chair?
The device version FDA cleared in 2018 covers male and female urinary incontinence, so the cleared use includes men.
The published study described on this page enrolled 35 women, so the independent evidence described here comes from women.
A licensed provider can talk through what is known for your situation.
Sources
Every number on this page comes from one of these sources and was checked against it.
- accessdata.fda.gov · U.S. Food and Drug Administration
- accessdata.fda.gov · U.S. Food and Drug Administration
- Emsella · bodybybtl.com
- Is the High-Intensity Focused Electromagnetic Energy an Effective Treatment for Urinary Incontinence in Women? · Tosun et al., Ther Clin Risk Manag, 2024
- fda.gov · U.S. Food and Drug Administration
Medical disclaimer. MedSpaStandard is for education only and is not medical advice. Talk to a licensed provider about your own health, and check any provider's license with your state board.