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510(k) K902141

ANOLIFT - PORTABLE & ANOLIFT - GANTRY by Anodyne Corp. — Product Code FSA

K902141 is an FDA 510(k) premarket notification submitted by Anodyne Corp. for the device "ANOLIFT - PORTABLE & ANOLIFT - GANTRY". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code FSA (Lift, Patient, Non-Ac-Powered), a Class I device regulated under 21 CFR 880.5510. Anodyne Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
May 15, 1990
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 Anodyne Corp.

  • K160710 — Oasis Lacrimal Intubation Set (May 13, 2016)

Other clearances for product code FSA

  • K942807 — SURGICAL LIFT SHEET (August 2, 1994)
  • K930625 — SANITAS PATIENT LIFT (September 13, 1993)
  • 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)
  • K841395 — SHOWER TROLLEY (May 7, 1984)
  • 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