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510(k) K802780

JACKSON HYDRO SYSTEM by S. Jackson, Inc. — Product Code FNG

K802780 is an FDA 510(k) premarket notification submitted by S. Jackson, Inc. for the device "JACKSON HYDRO SYSTEM". The FDA issued a decision of Substantially Equivalent on December 10, 1980. The device falls under product code FNG (Lift, Patient, Ac-Powered), a Class II device regulated under 21 CFR 880.5500. S. Jackson, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1980
Date Received
November 5, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lift, Patient, Ac-Powered
Device Class
Class II
Regulation Number
880.5500
Review Panel
HO
Submission Type

Other clearances by S. Jackson, Inc.

  • K080216 — SUPRAMESH EXTRA (September 15, 2008)
  • K973379 — STERILE SUPRAFOIL SMOOTH NYLON FOIL SHEETS (September 25, 1997)
  • K931613 — SUPRAMID SUTURE (December 17, 1993)
  • K931612 — NYLAMID SUTURE (December 17, 1993)
  • K931614 — MOPYLEN SUTURE (December 17, 1993)
  • K922630 — MOPYLEN (October 20, 1992)
  • K912429 — N80-838 SUPRAMID EXTRA SUTURE (October 2, 1991)
  • K904052 — SUPRAMID EXTRA SUTURES (October 25, 1990)
  • K852011 — NYLAMID MESH PAD FULL & HALF (June 11, 1985)
  • K831725 — FOIL IN 3 FORMS-NON-STERILE SHEETS (August 16, 1983)

Other clearances for product code FNG

  • K121287 — HT-WEDGE (October 3, 2012)
  • K041503 — HOVERJACK AIR PATIENT LIFT DEVICE (August 12, 2004)
  • K940872 — PATIENT SUPPORT SYSTEM (October 13, 1994)
  • K935351 — A.C. POWER PATIENT LIFT (February 28, 1994)
  • K926411 — SAF-LIFT/SAF-KARY (March 31, 1993)
  • K912769 — PATIENT LIFT AND TRANSPORT (October 2, 1991)
  • K905414 — MANGAR BOOSTER (March 5, 1991)
  • K895677 — THE MURRAY MOBILIFT(TM) (October 26, 1990)
  • K903723 — BARRIER FREE CEILING LIFT, MDLS HRS-1/2F,1/4F,1/6F (September 24, 1990)
  • K896848 — LIFT MASTER PATIENT LIFT (May 29, 1990)

FDA data resources