DeviceClearance

Product code INK— Physical Medicine

HAUSTED POWERTRAN SERIES STRETCHER

Classification name
Stretcher, Wheeled, Powered
Device class
Class 2
Regulation
21 CFR 890.3690
Advisory panel
Physical Medicine
Total cleared
12
First cleared
Most recent

Market context for product code INK

FDA has cleared 12 devices under product code INK between 1977 and 2016, filed by 12 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

Top applicants under product code INK

Adverse events under product code INK

product code INK
Malfunction
708
Other
1
Total
709

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 INK

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