DeviceClearance

Product code INO— Physical Medicine

577ES (ERGOSENSE)

Classification name
Chair, Positioning, Electric
Device class
Class 2
Regulation
21 CFR 890.3110
Advisory panel
Physical Medicine
Total cleared
53
First cleared
Most recent

Market context for product code INO

FDA has cleared 53 devices under product code INO between 1978 and 2014, filed by 43 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code INO

Adverse events under product code INO

product code INO
Death
6
Total
6

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code INO

Data sourced from openFDA. This site is unofficial and independent of the FDA.