Home / 510(k) Clearances / K970636

510(k) K970636

TOTALCARE., MODULAR THERAPY SYSTEM (MTS) by Hill-Rom, Inc. — Product Code IOQ

K970636 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "TOTALCARE., MODULAR THERAPY SYSTEM (MTS)". The FDA issued a decision of Substantially Equivalent on August 26, 1997. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1997
Date Received
February 20, 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 Hill-Rom, Inc.

  • K202018 — Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom H (March 4, 2021)
  • K180079 — Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different (May 7, 2018)
  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K112502 — PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 (September 19, 2011)
  • K013709 — HILL-ROM PRIMAVIEW MONITOR SYSTEM (November 16, 2001)
  • K973705 — CONTOR TABLE SURFACE (August 7, 1998)
  • K981081 — BRIGHTSTAR (April 29, 1998)
  • K972111 — RUMORS DYNAMIC AIR THERAPY UNIT (February 2, 1998)
  • K971366 — INCUWARMER (January 5, 1998)

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)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 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