Identity
- Trade Name
- UltraMIST Generator FDA UDI
- Generic Name
- Wound therapy ultrasound system generator FDA UDI
- Device Name
- A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound to promote healing of the wound without direct wound contact. The generator generates radio-frequency electrical energy which is subsequently transduced into ultrasound energy in the system treatment wand and pumps a fluid solution for the production of an ultrasound-conductive mist used to promote wound healing. The generator is intended to be used in conjunction with a system treatment wand and fluid source such as saline. FDA UDI
- Model / Reference
- CP-80031 FDA UDI
- Description
- A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound to promote healing of the wound without direct wound contact. The generator generates radio-frequency electrical energy which is subsequently transduced into ultrasound energy in the system treatment wand and pumps a fluid solution for the production of an ultrasound-conductive mist used to promote wound healing. The generator is intended to be used in conjunction with a system treatment wand and fluid source such as saline. FDA UDI
Identifiers
- Catalog Number
- CP-80031 FDA UDI
- Primary DI / UDI-DI
- 00816789010211 FDA UDI
- 510(k) Number
- K140782 FDA UDI
- FDA Product Code
- NRB FDA UDI
- GMDN Term
- Wound therapy ultrasound system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Wound therapy ultrasound system generator
UltraMIST Generator by Alliqua Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K140782 also covers:
- UltraMIST Applicator — ALLIQUA BIOMEDICAL, INC.
- UltraMIST Treatment Wand — ALLIQUA BIOMEDICAL, INC.
- UltraMIST Generator — SANUWAVE Health, Inc.
- UltraMIST Single Use Applicator — SANUWAVE Health, Inc.
- UltraMIST Single Use Applicator (12 Pack) — SANUWAVE Health, Inc.
- UltraMIST Treatment Wand — SANUWAVE Health, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alliqua Biomedical, Inc.
Sources (1)
- FDA UDI d0279ca9-65ed-4a6f-adab-6b92373e6672 37 fields · synced May 30, 2026