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AROBELLA MEDICAL, LLC

Last updated September 17, 2026

Information

Country: US
Address: 111 Cheshire Lane, Suite 700, Minnetonka, MN, 55305
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EUDAMED SRN: —
FDA FEI Number: 3007225330
DUNS Number: —

Catalogue (23)

Device	Model / Reference	Registries	Class	Status
Qoustic Wound Therapy System®, Model AR1000 Series	AR1000	FDA UDI	Class II	Unknown
Qoustic Choice® Wound Therapy System, Model AR1000D Series	AR1000D	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7	AR1000/B	FDA UDI	Class II	Active
Qoustic Wound Therapy System® Ultrasonic Generator	AR1000	FDA UDI	Class II	Unknown
Qoustic Choice® Wound Therapy System, Disposable Tubing Set	AR1000D	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12	AR1000D	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base	AR1000	FDA UDI	Class II	Active
Qoustic Wound Therapy System® Ultrasonic Generator	AR1000B	FDA UDI	Class II	Active
Qoustic Wound Therapy System® Converter Hand Piece	AR1000	FDA UDI	Class II	Active
Qoustic Wound Therapy System® Qoustic Key®	AR1000B/D	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6	AR1000/B	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1	AR1000/B	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11	AR1000D	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support	AR1000	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13	AR1000D	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4	AR1000/B	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Model AR1000B Series	AR1000B	FDA UDI	Class II	Active
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14	AR1000D	FDA UDI	Class II	Active
Qoustic Choice® Wound Therapy System Ultrasonic Generator	AR1000D	FDA UDI	Class II	Active
Qoustic Choice® Wound Therapy System Converter Hand Piece	AR1000D	FDA UDI	Class II	Active
As 1000 Ultrasound Wound Therapy System	K091038	FDA 510(k)	Class II	Active
Ar1000 Series Ultrasonic Wound Therapy System	K131096	FDA 510(k)	Class II	Active
Ar1000 Ultrasonic Wound Therapy System	K062544	FDA 510(k)	U	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 5, 2012	Z-0534-2013	—	terminated	This recall has been initiated because the Arobella Medical 6mm Qurette Q07 Lot Numbers 0001 and 0002 can fracture during use and may release a fragment or fragments. The 6 mm Qurette is a component of the AR1000 Quostic Wound Therapy System.