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510(k) K941610

CLENSICAIR LOW AIRLOSS HYDROTHERAPY by Support Systems Intl. — Product Code IOQ

K941610 is an FDA 510(k) premarket notification submitted by Support Systems Intl. for the device "CLENSICAIR LOW AIRLOSS HYDROTHERAPY". The FDA issued a decision of Substantially Equivalent on February 10, 1995. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Support Systems Intl. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1995
Date Received
March 31, 1994
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 Support Systems Intl.

  • K940662 — I-5000 (June 15, 1994)
  • K922973 — RESTCUE CC (July 30, 1992)
  • K920382 — FLEXICAIR LOW AIRLOSS THERAPY UNIT (April 7, 1992)
  • K920112 — CLINITRON C-II (January 24, 1992)

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