Home / 510(k) Clearances / K893801

510(k) K893801

M.F.S. LOW AIR LOSS PULSATING BED by Medical Flotation Systems, Inc. — Product Code IOQ

K893801 is an FDA 510(k) premarket notification submitted by Medical Flotation Systems, Inc. for the device "M.F.S. LOW AIR LOSS PULSATING BED". The FDA issued a decision of Substantially Equivalent on July 25, 1989. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Medical Flotation Systems, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1989
Date Received
May 22, 1989
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

Other clearances by Medical Flotation Systems, Inc.

  • K890200 — PNEUMATIC DORSIFLEXOR (February 3, 1989)
  • K884908 — ULTRAFLOTATION MEDICAL WHEELCHAIR (December 27, 1988)
  • K884907 — BUMPY MEDICAL MASSAGE MAT (December 27, 1988)
  • K882607 — ULTRAFLOTATION BED (October 14, 1988)

Other clearances for product code IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources