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510(k) K811482

INCONTINENT PAD by Fred Sammons, Inc. — Product Code KNO

K811482 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "INCONTINENT PAD". The FDA issued a decision of Substantially Equivalent on August 25, 1981. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1981
Date Received
May 26, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Wheelchair
Device Class
Class I
Regulation Number
890.3910
Review Panel
PM
Submission Type

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)

Other clearances for product code KNO

  • K870298 — REDMAN ACCESSORIES (February 26, 1987)
  • K823645 — VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR (January 21, 1983)
  • K823646 — FRICTION FEEDER (January 21, 1983)
  • K823816 — WHEELCHAIR PATIENT RESTRAINTS (January 14, 1983)
  • K823636 — ARM THROUGH FOR WHEELCHAIR BK-6459-01 & (December 28, 1982)
  • K823635 — CUSHIONS FOR WHEELCHAIR ARMS (December 28, 1982)
  • K823596 — CLAMP ON HOLDER FOR A GLASS OR CUP (December 22, 1982)
  • K823595 — HEAD SUPPORT FOR WHEELCHAIR (December 22, 1982)
  • K821642 — WHEEL CHAIR ACCESSORIES (June 11, 1982)
  • K820964 — WHEELCHAIR PAL (April 16, 1982)

FDA data resources