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510(k) K841395

SHOWER TROLLEY by Setma, Inc. — Product Code FSA

K841395 is an FDA 510(k) premarket notification submitted by Setma, Inc. for the device "SHOWER TROLLEY". The FDA issued a decision of Substantially Equivalent on May 7, 1984. The device falls under product code FSA (Lift, Patient, Non-Ac-Powered), a Class I device regulated under 21 CFR 880.5510. Setma, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1984
Date Received
April 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Non-Ac-Powered
Device Class
Class I
Regulation Number
880.5510
Review Panel
HO
Submission Type

Other clearances by Setma, Inc.

  • K854861 — SETMA HYGIA BATH MODEL ST 7200 (January 3, 1986)
  • K854263 — SETMA FHT, MODEL ST 8130 (November 13, 1985)
  • K853163 — SETMA VHT (November 5, 1985)
  • K841397 — BURN BATH (May 18, 1984)
  • K841398 — VARIABLE HEIGHT TRANSFER CHAIR (May 7, 1984)
  • K841396 — TRANSFER TROLLEY (May 7, 1984)

Other clearances for product code FSA

  • K942807 — SURGICAL LIFT SHEET (August 2, 1994)
  • K930625 — SANITAS PATIENT LIFT (September 13, 1993)
  • K902141 — ANOLIFT - PORTABLE & ANOLIFT - GANTRY (September 12, 1990)
  • K860837 — HOYER ONE-TOUCH POWER LIFTER (March 27, 1986)
  • K851844 — MOLIFT (May 17, 1985)
  • K844976 — MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT (April 1, 1985)
  • K841398 — VARIABLE HEIGHT TRANSFER CHAIR (May 7, 1984)
  • K840997 — BATTERY POWERED PATIENT LIFT (April 17, 1984)
  • K823206 — MARTIN PELVIC LIFT (April 28, 1983)
  • K811899 — CENTURY LIFT TRANSFER SYSTEM (July 23, 1981)

FDA data resources