Sofwave Pure Impact
EMS/HIFEM muscle stimulation · Electrical muscle stimulation (PlyoPulse)
Technology: EMS & Muscle Stimulation
At a glance
- New price
- Not published
- FDA status
Record scope: 510(k): K251746 (decision 2 Jul 2025). Checked 4 Sep 2026.
- Supplies & recurring costs
- Supply details not yet documented.
Sources and data on file
Data on file
- Recurring consumables
- Not verified
- FDA
- FDA record cited — see scopeK251746
- Used asking prices
- Not verified
- This panel shows a per-treatment supply cost only when a recorded figure has a dated source.
- Bottle prices and estimates may still appear under Treatment & running costs.
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Figures are reference points, not current offers.
Read FDA-cleared indicationsExact wording from 1 FDA record
K251746 (Sofwave Medical, Ltd., 2025)
Pure Impact is indicated to be used for: • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. • Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas. • The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training. The indications for use statement for the subject device is identical to that of the previously cleared Pure Impact Module of the SofWave System in K250146.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Page updated: October 1, 2026 · How we verify
New-equipment price not yet documented
For a complete budget, ask for an itemized quote covering the device, accessories, training and service.
Price sourcesSources, dates and configurations
No price sources are documented yet. Ask the seller for a current, itemized quote.
Key factsCompany, specifications and verification dates
| Manufacturer | Sofwave |
|---|---|
| Company | Owner: Publicly traded (Tel Aviv Stock Exchange: SOFW) (public company, since 2021) · Distribution: direct |
| Parent company | Sofwave Medical |
| Brand owner | Sofwave |
| Built by (OEM) | Sofwave Medical Ltd. |
| Category | Body Contouring |
| Technology | Electrical muscle stimulation (PlyoPulse) |
| FDA status | FDA record cited — see scope |
| 510(k) citation | K251746 |
| New price range | Not published |
| Used price reference | Not published |
| Consumables | Not published |
| Launch year | Not published |
| Pricing | Not published |
| Manufacturer-source documents checked | Not published |
Overview
Pure Impact is a Sofwave muscle-stimulation platform using PlyoPulse EMS technology. It is a separate treatment technology from Sofwave’s ultrasound system.
Confirm the offered configuration and its muscle-toning indications with the supplier.
FDA & regulatory detailClearance timeline, authorization route and citation notes
510(k): K251746 (decision 2 Jul 2025). Checked 4 Sep 2026.
FDA-cleared indications (verbatim)
K251746 (Sofwave Medical, Ltd., 2025)
Pure Impact is indicated to be used for: • Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen. • Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas. • The Pure Impact is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Pure Impact is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The various types of muscle work that the Pure Impact can impose on the stimulated muscles are able to improve or facilitate muscle performance. The Pure Impact may therefore be considered a technique of muscle training. The indications for use statement for the subject device is identical to that of the previously cleared Pure Impact Module of the SofWave System in K250146.
Verbatim from the FDA 510(k) summary, retrieved 8 Sep 2026.
Marketed for
HIFU / Ultrasound — Electromagnetic muscle stimulation
Marketing claims are the manufacturer's own and are not the same as a cleared indication.
Parent company: Sofwave Medical
Legal manufacturer: Sofwave Medical Ltd. (Israel)
Applicant on the FDA record
Sofwave Medical Ltd.The applicant named on the FDA record can differ from the brand shown on the device.
Regulatory data comes from public FDA records and may lag recent updates. Confirm the applicable status and documentation before purchase.
Look-alike devices
Comparing an unbranded muscle-stimulation unit? Check the exact model rather than relying on similar photos or treatment claims.
Listed manufacturer for this profile: Sofwave Medical Ltd.
- FDA record: Match any claimed 510(k) or De Novo number to the exact model and applicant in the FDA database.
- Support: Get written warranty, training, consumables and service terms from the seller.
- Financing: Confirm availability for the exact unit before including it in your budget.
We do not profile these unbranded units or verify their support and financing terms. Any FDA record cited here must be read for its exact model and scope; it does not automatically cover similar-looking units.
Treatment & running costs
Treatment and running-cost details aren’t documented yet.
Ask the supplier for the session schedule, supplies per treatment and annual service costs.
Use your own figures in the calculatorPayback calculatorEnter your quote, volume and running costs
Estimate your payback
Enter your quote and treatment costs for Sofwave Pure Impact. Published figures appear where available; review them before using the estimate.
No verified per-treatment supply cost is on file. Enter your own allowance. Use $0 only if you have confirmed that it applies to your practice.
New price not published — enter the number on your quote.
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No sourced per-session price on file — enter what you charge.
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Annual service contract ÷ 12, if you carry one.
Your estimate
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Warranty & serviceWhat to confirm in writing before you buy
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Chains using this device
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Current alternatives
Current catalog models to research. Confirm availability and configuration with the supplier.
Allergan Aesthetics CoolTone
EMS/HIFEM muscle stimulation
New-equipment price not yet documented.
Research comparisons
Includes current and older models.
History8 tracked changes
Every tracked change to pricing, lifecycle status, FDA data and warranty terms — newest first.
October 1, 2026
Sourced profile overview
Added a neutral overview from the linked manufacturer or official US distributor source. This is field-specific sourcing, not verification of every other profile field.
Source: https://sofwave.com/news/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology
September 18, 2026
technology
Electromagnetic muscle stimulation → Electrical muscle stimulation (PlyoPulse)
Corrected from manufacturer primary documentation. Pure Impact uses electrical muscle stimulation; the separate Sofwave skin platform uses ultrasound. This correction does not change regulatory indications or claims.
Source: https://sofwave.com/news/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology
September 18, 2026
technology subcategory
HIFU / Ultrasound → EMS / muscle stimulation
Corrected from manufacturer primary documentation. Pure Impact uses electrical muscle stimulation; the separate Sofwave skin platform uses ultrasound. This correction does not change regulatory indications or claims.
Source: https://sofwave.com/news/sofwave-medical-receives-510k-marketing-clearance-for-pure-impact-strength-and-muscle-toning-body-module-utilizing-plyopulse-ems-technology
September 4, 2026
FDA status
Unknown → Cleared
Clearance located on openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA status
Unknown → Cleared
Source: Catalog update
September 4, 2026
510(k) numbers
K-number set re-verified against openFDA
Source: Council round 2 audit, verified on openFDA 2026-09-04
September 4, 2026
FDA K-numbers
Source: Catalog update
September 4, 2026
FDA source URL
Source: Catalog update
Cite this data: The Aesthetic Index, "Sofwave Pure Impact — pricing, FDA status and cost to own", aestheticindex.co (accessed November 3, 2026).
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