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510(k) K821010

BATHTUB TRANSFER BENCH by Guardian Products Co., Inc. — Product Code IKX

K821010 is an FDA 510(k) premarket notification submitted by Guardian Products Co., Inc. for the device "BATHTUB TRANSFER BENCH". The FDA issued a decision of Substantially Equivalent on Apr 21, 1982. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Guardian Products Co., Inc. has 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 21, 1982
Date Received
Apr 12, 1982
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
510(k) Exempt

Other clearances by Guardian Products Co., Inc.

  • K915108 — FOLDING WHEELCHAIR (Jan 13, 1992)
  • K842650 — WALL GRAB BARS 98130-98136 (Aug 10, 1984)
  • K842649 — BATH TUB TRANSFER CHAIR (Aug 10, 1984)
  • K842651 — COMMODE CHAIR 98200 (Aug 7, 1984)
  • K821009 — BATHTUB GRAB BAR (Apr 21, 1982)
  • K790299 — FOREARM-CANE (Feb 21, 1979)
  • K772049 — WALKING AID (Nov 11, 1977)

Other clearances for product code IKX

  • K862895 — TRICYCLES (Aug 13, 1986)
  • K842650 — WALL GRAB BARS 98130-98136 (Aug 10, 1984)
  • K831541 — TUB TRANSFER BENCH BK6481 (Jun 2, 1983)
  • K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM (Jan 21, 1983)
  • K823640 — BATH TUB SAFETY BAR (Jan 21, 1983)
  • K823634 — CHAIR OR BED LEG EXTENDERS (Dec 28, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (Nov 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (Nov 5, 1982)
  • K821903 — DISC-O-AID (Jul 20, 1982)
  • K813629 — BK-6111 HI-D TRANSFER BOARD (Jan 19, 1982)

FDA data resources