arobella.comAR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
AROBELLA MEDICAL, LLC
AROBELLA MEDICAL, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007225330 | 3007225330 | AROBELLA MEDICAL, LLC | 1 | N | 2026-01-01 | 111 Cheshire Lane, Suite 700 Minnetonka MN US 55305 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00853077002008 | Qoustic Wound Therapy System®, Model AR1000 Series - Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002008 | Qoustic Wound Therapy System®, Model AR1000 Series - Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management | 952-345-6840 | service@arobella.com |
| 00853077002015 | Qoustic Wound Therapy System® Converter Hand Piece - Hand Piece, Converter, Qoustic Wound Therapy System®, Model AR1000 Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002015 | Qoustic Wound Therapy System® Converter Hand Piece - Hand Piece, Converter, Qoustic Wound Therapy System®, Model AR1000 Series | 952-345-6840 | service@arobella.com |
| 00853077002022 | Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support - Support, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002022 | Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support - Support, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series | 952-345-6840 | service@arobella.com |
| 00853077002039 | Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base - Base, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002039 | Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base - Base, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series | 952-345-6840 | service@arobella.com |
| 00853077002183 | Qoustic Choice® Wound Therapy System, Disposable Tubing Set - Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002183 | Qoustic Choice® Wound Therapy System, Disposable Tubing Set - Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series | 952-345-6840 | service@arobella.com |
| 00853077002220 | Qoustic Wound Therapy System® Ultrasonic Generator - Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002220 | Qoustic Wound Therapy System® Ultrasonic Generator - Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series | 952-345-6840 | service@arobella.com |
| 00853077002237 | Qoustic Wound Therapy System® Ultrasonic Generator - Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002237 | Qoustic Wound Therapy System® Ultrasonic Generator - Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series | 952-345-6840 | service@arobella.com |
| 00853077002244 | Qoustic Choice® Wound Therapy System Ultrasonic Generator - Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series | 952-288-2810 | lyoshikawa@arobella.com |
| 00853077002244 | Qoustic Choice® Wound Therapy System Ultrasonic Generator - Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series | 952-345-6840 | service@arobella.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 83422 | 1662665457 | K131096 | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM | NRB | 2014-05-16 |
| 83422 | 2037518908 | K091038 | AS 1000 ULTRASOUND WOUND THERAPY SYSTEM | NRB | 2009-06-19 |
| 83422 | 1379528711 | K062544 | AR1000 ULTRASONIC WOUND THERAPY SYSTEM | LFL | 2007-01-03 |
Product Codes Associated With Registrations#
PMN#
AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
AROBELLA MEDICAL, LLC
AR1000 ULTRASONIC WOUND THERAPY SYSTEM
AROBELLA MEDICAL, LLC
GUDID#
Qoustic Wound Therapy System® Ultrasonic Generator - Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series
2017-03-01
Qoustic Wound Therapy System® Ultrasonic Generator - Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series
2017-03-01
Qoustic Choice® Wound Therapy System Ultrasonic Generator - Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series
2017-03-01
Qoustic Choice® Wound Therapy System, Disposable Tubing Set - Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series
2017-01-20
Qoustic Wound Therapy System®, Model AR1000 Series - Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management
2017-03-01
Qoustic Wound Therapy System® Converter Hand Piece - Hand Piece, Converter, Qoustic Wound Therapy System®, Model AR1000 Series
2017-03-01
Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support - Support, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series
2017-03-01
Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base - Base, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 + Qoustic Qurette® Shroud, Type P
2017-03-01
Qoustic Wound Therapy System®, Model AR1000B Series - Qoustic Wound Therapy System®, Model AR1000B Series - ultrasound wound therapy system for wound debridement and management
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 + Qoustic Qurette® Shroud, Type P
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 + Qoustic Qurette® Shroud, Type P
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7 + Qoustic Qurette® Shroud, Type P
2017-03-01
Qoustic Wound Therapy System® Qoustic Key® - Qoustic Key®, Qoustic Wound Therapy System®, Model AR1000 Series, for systems set as (M) to use Pre-Paid Minutes (PPM)
2017-03-01
Qoustic Choice® Wound Therapy System, Model AR1000D Series - Qoustic Choice® Wound Therapy System, Model AR1000D Series - ultrasound wound therapy system for wound debridement and management
2017-03-01
Qoustic Choice® Wound Therapy System Converter Hand Piece - Hand Piece, Converter, Qoustic Choice® Wound Therapy System, Model AR1000D Series
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 + Shroud, Type PWD
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 + Qoustic Qurette® Shroud, Type PWD
2017-03-01
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13 + Qoustic Qurette® Shroud, Type PWD
2017-03-01
Qoustic Choice® Wound Therapy System, Disposable Tubing Set - Disposable Tubing Set, Qoustic Choice® Wound Therapy System, Model AR1000D Series
2017-01-20
Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 + Qoustic Qurette® Shroud, Type P
2017-03-01