MOC — Cushion, Flotation, Therapeutic Class II

FDA Device Classification

FDA product code MOC covers "Cushion, Flotation, Therapeutic", a Class II medical device regulated under 21 CFR 890.5170. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MOC
Device Class
Class II
Regulation Number
890.5170
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K063175medical technology systemsIPUP 200 (INTELLIGENT PRESSURE ULCER PREVENTION)March 14, 2008
K954162ergo-airERGOSEAT SYSTEMOctober 30, 1995