ULTRAMIST SYSTEM
Ultrasound wound therapy without touching the wound
METHOD
Non-contact, low-frequency ultrasound through a saline mist
FDA STATUS
510(k) cleared (K140782)
PER TREATMENT
One single-use applicator
OWNERSHIP
Purchase or 32-month lease-to-own
How It Works
UltraMIST treats the wound bed without touching it. The system uses low-frequency, low-intensity ultrasound to generate a saline mist, and the mist carries ultrasound energy to the wound.
| Component | What it is | Notes |
|---|---|---|
| Generator | Reusable unit that produces the ultrasound energy. | Purchased or leased with the system. |
| Treatment wand | Reusable handheld wand used with the applicator to deliver treatment. | Purchased or leased with the system. |
| Applicator | Single-use applicator used with the wand. | One per treatment. Sold by the box of 12. |
| Sterile saline | The fluid that forms the mist. | Supplied by the practice. |
Labeled Use
UltraMIST is a 510(k)-cleared prescription device (K140782). It is labeled to promote wound healing through wound cleansing and maintenance debridement, removing fibrin, yellow slough, tissue exudates, and bacteria. Refer to the instructions for use for indications, contraindications, warnings, and precautions.
MD Biologix LLC | 1750 Briercroft Ct., Suite 228, Carrollton, TX 75006 | mdbiologix.health
When to Consider UltraMIST
UltraMIST may be considered when the provider wants to cleanse and treat the wound bed without contact. The examples below are not a complete list.
Alternative to traditional debridement
UltraMIST may be appropriate as an alternative to debridement with a curette or blade, including for patients who struggle to tolerate it.
Plan coverage
The patient's plan covers MIST therapy and any required prior authorization is approved.
Patient fit
The patient meets the plan's criteria, and UltraMIST is appropriate for that patient under its instructions for use.
Provider choice
Some providers may prefer a non-contact approach for a given wound. Device selection is the provider's clinical decision.
When MIST may not be the fit, providers may consider XSONX for contact debridement.
Published studies on UltraMIST have looked at pain during treatment and after treatment. Your MD Biologix contact can share the references.
Clinical judgment and medical necessity supersede any use case on this page.
Purchase Options
Practices can purchase the UltraMIST system outright or through a 32-month lease-to-own program. Applicators are ordered separately, as needed.
| Option | Terms |
|---|---|
| Purchase | Paid in full before shipment. |
| 32-month lease-to-own |
|
| Treatment applicators | Sold by the box of 12. No monthly minimum. |
- Applicator orders of 1 box have shipping added to the invoice. Orders of 2 or more boxes include 2-day air shipping.
- Orders and invoices run through OneCare, the MD Biologix customer platform.
- Lease terms are set out in the MD Biologix lease agreement.
MD Biologix LLC | 1750 Briercroft Ct., Suite 228, Carrollton, TX 75006 | mdbiologix.health
Billing Reference
| Device | CPT code |
|---|---|
| UltraMIST | 97610 |
Code selection and coverage vary by payer, and some plans require prior authorization. Confirm with your coder and payer.
Frequently Asked Questions
Does UltraMIST touch the wound?
No. UltraMIST delivers ultrasound through a saline mist and does not contact the wound.
What does each treatment use?
One single-use applicator and sterile saline. Your practice supplies the saline.
Is UltraMIST FDA cleared?
Yes. UltraMIST is a 510(k)-cleared medical device (K140782).
Can we lease instead of buy?
Yes. The 32-month lease-to-own program has monthly payments that credit toward the buyout price, and title transfers to your practice at month 32.
Is there a minimum applicator order?
There is no monthly minimum. Applicators are sold by the box of 12.
How is UltraMIST different from XSONX?
UltraMIST is non-contact, low-frequency ultrasound delivered through a saline mist. XSONX is contact debridement using high-speed vibration. MD Biologix supplies both.
How do I order?
Contact our team for pricing, lease terms, and account setup.
Talk to our team about UltraMIST
Pricing, lease-to-own terms, and applicator orders for your practice.
UltraMIST® is a registered trademark of SANUWAVE Health, Inc. UltraMIST® is a 510(k)-cleared medical device. MD Biologix, LLC is a non-exclusive distributor of UltraMIST® and is not the manufacturer. Refer to the instructions for use for indications, contraindications, warnings, and precautions. The use cases on this page are examples and are not a complete list. Clinical judgment and medical necessity supersede any use case described here. This page is general reference only and is not clinical, coding, or legal advice.
MD Biologix LLC | 1750 Briercroft Ct., Suite 228, Carrollton, TX 75006 | mdbiologix.health