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Qoustic Wound Therapy System® Ultrasonic Generator

FDA UDI

Class II (US FDA UDI)

by Arobella Medical, Llc

Identity

Trade Name
Qoustic Wound Therapy System® Ultrasonic Generator FDA UDI
Generic Name
Ultrasonic surgical system generator FDA UDI
Device Name
Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series FDA UDI
Model / Reference
AR1000 FDA UDI
Description
Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series FDA UDI

Identifiers

Catalog Number
AR1000-GEN FDA UDI
Primary DI / UDI-DI
00853077002220 FDA UDI
510(k) Number
K062544 FDA UDI
K131096 FDA UDI
FDA Product Code
NRB FDA UDI
LFL FDA UDI
GMDN Term
Ultrasonic surgical system generator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4410 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI
Sterilization Method
Liquid Chemical FDA UDI

Dimensions & Sizes

Size
Weight — 18 Pound FDA UDI
Height — 12.25 Inch FDA UDI
Width — 19.5 Inch FDA UDI
Depth — 20.625 Inch FDA UDI

Qoustic Wound Therapy System® Ultrasonic Generator by Arobella Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K062544 also covers:

K131096 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Arobella Medical, Llc

Sources (1)

  • FDA UDI 0ff92f74-0fab-4374-9143-4398d68d8667 39 fields · synced Jun 8, 2026