Home / 510(k) Clearances / K810220

510(k) K810220

POWERED PATIENT SYSTEM by Tri W-G, Inc. — Product Code IKZ

K810220 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "POWERED PATIENT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 1981. The device falls under product code IKZ (Bed, Patient Rotation, Powered), a Class II device regulated under 21 CFR 890.5225. Tri W-G, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1981
Date Received
January 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Patient Rotation, Powered
Device Class
Class II
Regulation Number
890.5225
Review Panel
PM
Submission Type

Other clearances by Tri W-G, Inc.

  • K960196 — TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 (February 7, 1996)
  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K941720 — MODEL 747 AND 747-30 EXAM/TREATMENT TABLE (May 6, 1994)
  • K936303 — TREATMENT TABLE MODIFICATION (March 18, 1994)
  • K933119 — HI-LO TREATMENT TABLES (October 12, 1993)
  • K932746 — MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE (July 21, 1993)
  • K930802 — MODELS 642 & 643 TILT EXAM/TREATMENT TABLE (March 22, 1993)
  • K925594 — MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE (February 12, 1993)
  • K923325 — MODEL 600 MEDICAL TREATMENT TABLE (July 21, 1992)
  • K922980 — 745-M (MAGNUM) (July 13, 1992)

Other clearances for product code IKZ

  • K972486 — PRESSUREGUARD IV (February 20, 1998)
  • K972111 — RUMORS DYNAMIC AIR THERAPY UNIT (February 2, 1998)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
  • K954671 — THE FREEDOM BED (April 1, 1996)
  • K950756 — PULMONEX DYNAMIC AIR THERAPY UNIT (May 30, 1995)
  • K950681 — MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY (May 16, 1995)
  • K933964 — THE CRADLE (October 3, 1994)
  • K923710 — OSCILLAIR 3000 LOW AIR LOSS KINETIC THERAPY BED (March 22, 1993)
  • K922473 — TURN EZ BED DEVICE (September 9, 1992)
  • K905390 — KUDO (POWERED ROTATION BED) (January 8, 1991)

FDA data resources