510(k) K931594

THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM by Medical Device Inspection Co., Inc. — Product Code IOQ

K931594 is an FDA 510(k) premarket notification submitted by Medical Device Inspection Co., Inc. for the device "THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 1993. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Medical Device Inspection Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1993
Date Received
March 31, 1993
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