510(k) K091038

Device: AS 1000 ULTRASOUND WOUND THERAPY SYSTEM
Applicant: AROBELLA MEDICAL, LLC
510(k) number: K091038
Product code: NRB
Decision: Substantially Equivalent (SESE)
Decision date: 2009-06-19
Date received: 2009-04-13
Regulation: 878.4410
Classification name: Wound Cleaner, Ultrasound
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: ELIAZ BABAEV
Address: 5929 Baker Rd. Suite 470 Minnetonka MN US 55345 55345

FDA Registration Numbers#

1424263
1423662
1928237
2435119
3004028690
1062240
2183613
3004961578
1450662
1720929
3007225330

Source Documents#

Other 510(k) Records For Product Code NRB #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K162721	Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator	Alliqua Biomedical, Inc.	2016-12-22
K140782	ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR	Celleration, Inc.	2014-08-13
K131096	AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM	Arobella Medical, LLC	2014-05-16
K123980	SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES	Misonix, Inc.	2013-03-05
K122246	MIST 360 SINGLE USE APPLICATOR KIT, MIST 360 SINGLE USE APPLICATOR KIT, CASE OF 12	Celleration, Inc.	2012-08-13
K112782	MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES	Misonix, Inc.	2011-12-01
K050129	CELLERATION MIST THERAPY SYSTEM 5.1	Celleration, Inc.	2005-05-17
DEN040004	CELLERATION MIST THERAPY SYSTEM	Celleration	2004-06-25

Legacy Summary#

summary

FDA Review#

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