510(k) K926189

ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE by Bio Clinic Co. — Product Code IOQ

K926189 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE". The FDA issued a decision of Substantially Equivalent on June 24, 1993. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1993
Date Received
December 8, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
Submission Type