Home / 510(k) Clearances / K802603

510(k) K802603

ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION by Jefferson Industries, Inc. — Product Code KID

K802603 is an FDA 510(k) premarket notification submitted by Jefferson Industries, Inc. for the device "ECONO-FLOAT WHEELCHAIR FLOTATION CUSHION". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code KID (Restraint, Wheelchair, Non-Protective), a Class I device regulated under 21 CFR 890.3910. Jefferson Industries, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Wheelchair, Non-Protective
Device Class
Class I
Regulation Number
890.3910
Review Panel
PM
Submission Type

Other clearances by Jefferson Industries, Inc.

  • K813225 — GEL FLOTATION CUSHION (December 3, 1981)
  • K813226 — GEL FLOTATION MATTRESS (December 2, 1981)
  • K780779 — ECONO-FLOAT WATER FLOTATION MATTRESS (May 19, 1978)

Other clearances for product code KID

  • K963479 — WHEELCHAIR BELT (January 24, 1997)
  • K963475 — PONCHO VEST RESTRAINT (January 22, 1997)
  • K963480 — MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER (January 22, 1997)
  • K963459 — SUPPORT VEST (October 15, 1996)
  • K963461 — SAFETY PONCHO/SHOULDER STRAP PONCHO (October 11, 1996)
  • K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (October 8, 1996)

FDA data resources