The following data is part of a premarket notification filed by Arobella Medical, Llc with the FDA for Ar1000 Series Ultrasonic Wound Therapy System.
| Device ID | K131096 |
| 510k Number | K131096 |
| Device Name: | AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM |
| Classification | Wound Cleaner, Ultrasound |
| Applicant | AROBELLA MEDICAL, LLC 5929 BAKER ROAD SUITE 470 Minnetonka, MN 55345 |
| Contact | Matthew Berscheid |
| Correspondent | Matthew Berscheid AROBELLA MEDICAL, LLC 5929 BAKER ROAD SUITE 470 Minnetonka, MN 55345 |
| Product Code | NRB |
| CFR Regulation Number | 878.4410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-18 |
| Decision Date | 2014-05-16 |
| Summary: | summary |