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510(k) K842650

WALL GRAB BARS 98130-98136 by Guardian Products Co., Inc. — Product Code IKX

K842650 is an FDA 510(k) premarket notification submitted by Guardian Products Co., Inc. for the device "WALL GRAB BARS 98130-98136". The FDA issued a decision of Substantially Equivalent on August 10, 1984. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Guardian Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1984
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Transfer
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by Guardian Products Co., Inc.

  • K915108 — FOLDING WHEELCHAIR (January 13, 1992)
  • K842649 — BATH TUB TRANSFER CHAIR (August 10, 1984)
  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K821009 — BATHTUB GRAB BAR (April 21, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K790299 — FOREARM-CANE (February 21, 1979)
  • K772049 — WALKING AID (November 11, 1977)

Other clearances for product code IKX

  • K862895 — TRICYCLES (August 13, 1986)
  • K831541 — TUB TRANSFER BENCH BK6481 (June 2, 1983)
  • K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM (January 21, 1983)
  • K823640 — BATH TUB SAFETY BAR (January 21, 1983)
  • K823634 — CHAIR OR BED LEG EXTENDERS (December 28, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K821903 — DISC-O-AID (July 20, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K813629 — BK-6111 HI-D TRANSFER BOARD (January 19, 1982)

FDA data resources