Home / 510(k) Clearances / K811301

510(k) K811301

TUBMATE by American Stair-Glide Corp. — Product Code ILS

K811301 is an FDA 510(k) premarket notification submitted by American Stair-Glide Corp. for the device "TUBMATE". The FDA issued a decision of Substantially Equivalent on May 27, 1981. The device falls under product code ILS (Adaptor, Hygiene), a Class I device regulated under 21 CFR 890.5050. American Stair-Glide Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1981
Date Received
May 11, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Hygiene
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by American Stair-Glide Corp.

  • K941642 — ASCENDA (June 13, 1994)

Other clearances for product code ILS

  • K852049 — MEDICAL TOILET SEAT (June 24, 1985)
  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)
  • K830425 — TOILET SEAT RAISED (May 9, 1983)
  • K830852 — SHOWER STOOL W/HANDLES (April 5, 1983)
  • K823641 — BATHING CHAIR FOR CHILD (January 21, 1983)
  • K823626 — DISPOSABLE TOOTH BRUSH (December 30, 1982)
  • K823606 — PLASTIC BREAK RESISTANT MIRROR (December 28, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)

FDA data resources