FDA.reportPublic FDA data

Qoustic Wound Therapy System®, Model AR1000 Series

Primary DI
00853077002008
Brand
Qoustic Wound Therapy System®, Model AR1000 Series
Company
AROBELLA MEDICAL, LLC
Model
AR1000
Catalog number
AR1000-SYS
Device description
Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management
Published
2017-03-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFLInstrument, Ultrasonic Surgical
NRBWound Cleaner, Ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFLInstrument, Ultrasonic SurgicalUnknownU
NRBWound Cleaner, UltrasoundGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K062544000
K131096000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K062544000AR1000 ULTRASONIC WOUND THERAPY SYSTEMArobella Medical, LLC2007-01-03LFL
K131096000AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEMArobella Medical, LLC2014-05-16NRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853077002008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853077002008008530770020088530770020080853077002008

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue ultrasonic surgical systemAn assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth20.625Inch
Height12.25Inch
Weight23Pound
Width19.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization"", ""Liquid Chemical""]"
High-level Disinfectant;Moist Heat or Steam Sterilization;Liquid Chemical

Contacts#

Phone, Email table
PhoneEmail
952-288-2810lyoshikawa@arobella.com
952-345-6840service@arobella.com

Regulatory Flags#

DUNS number
839978876
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853077002220Qoustic Wound Therapy System® Ultrasonic GeneratorAR1000AR1000-GEN2017-03-01
00853077002237Qoustic Wound Therapy System® Ultrasonic GeneratorAR1000BAR1000B-GEN2017-03-01
00853077002244Qoustic Choice® Wound Therapy System Ultrasonic GeneratorAR1000DAR1000D-GEN2017-03-01
00853077002183Qoustic Choice® Wound Therapy System, Disposable Tubing SetAR1000DAR1000D-DTS2017-01-20
00853077002015Qoustic Wound Therapy System® Converter Hand PieceAR1000AR1000-H/P2017-03-01
00853077002022Qoustic Wound Therapy System®, Cart, AR Series, Type 1, SupportAR1000AR1000-CRT1A2017-03-01
00853077002039Qoustic Wound Therapy System®, Cart, AR Series, Type 1, BaseAR1000AR1000-CRT1B2017-03-01
00853077002060Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1AR1000/BAR1000-QT12017-03-01
00853077002077Qoustic Wound Therapy System®, Model AR1000B SeriesAR1000BAR1000B-SYS2017-03-01
00853077002091Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4AR1000/BAR1000-QT42017-03-01
00853077002107Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6AR1000/BAR1000-QT62017-03-01
00853077002114Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 7AR1000/BAR1000-QT72017-03-01
00853077002121Qoustic Wound Therapy System® Qoustic Key®AR1000B/DAR1000-KEY2017-03-01
00853077002138Qoustic Choice® Wound Therapy System, Model AR1000D SeriesAR1000DAR1000D-SYS2017-03-01
00853077002145Qoustic Choice® Wound Therapy System Converter Hand PieceAR1000DAR1000D-H/P2017-03-01
00853077002152Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11AR1000DAR1000D-QT112017-03-01
00853077002169Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12AR1000DAR1000D-QT122017-03-01
00853077002176Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 13AR1000DAR1000D-QT132017-03-01
10853077002203Qoustic Choice® Wound Therapy System, Disposable Tubing SetAR1000DAR1000D-DTS2017-01-20
00853077002213Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14AR1000DAR1000D-QT142017-03-01

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Primary DI, Brand, Company table
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