Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K141076Substantially equivalent (SESE) · 2014-11-14clearance family
Manufacturer compliance record
None in the loaded window.
Similar devices
- Reserv BOXOUT, LLC
- "1.5"" x 2.5"" oval pigtail electrode (10/bg)" BIOMEDICAL LIFE SYSTEMS, INC.
- "1.5"" x 2.5"" oval pigtail electrode" BIOMEDICAL LIFE SYSTEMS, INC.
- "1.5"" x 2.5"" oval pigtail eletrode" BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" round electrode " BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" round electrode ctn" BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" round electrode" BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" square fabric electrode" ELITE MEDICAL SUPPLY OF NY
- "2"" x 2"" Rectangle Electrodes" BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" x 2"" pigtail electrode " BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" x 2"" pigtail electrode - Inner Box " BIOMEDICAL LIFE SYSTEMS, INC.
- "2"" x 2"" pigtail electrode" BIOMEDICAL LIFE SYSTEMS, INC.
Select up to two to place side-by-side with this device.