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510(k) K970363

HYDROTEC LOW AIR LOSS THERAPY BED by Apex Metal, Inc. — Product Code IOQ

K970363 is an FDA 510(k) premarket notification submitted by Apex Metal, Inc. for the device "HYDROTEC LOW AIR LOSS THERAPY BED". The FDA issued a decision of Substantially Equivalent on November 17, 1997. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Apex Metal, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 1997
Date Received
January 31, 1997
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 Apex Metal, Inc.

  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970362 — CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM (May 16, 1997)

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)
  • 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)
  • K945729 — DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE (February 27, 1995)

FDA data resources