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510(k) K800958

PERSONAL SITZ BATH KIT by The Healthcare Group Laboratories, Inc. — Product Code KTC

K800958 is an FDA 510(k) premarket notification submitted by The Healthcare Group Laboratories, Inc. for the device "PERSONAL SITZ BATH KIT". The FDA issued a decision of Substantially Equivalent on May 2, 1980. The device falls under product code KTC (Bath, Sitz, Nonpowered), a Class I device regulated under 21 CFR 890.5125. The Healthcare Group Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1980
Date Received
April 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Sitz, Nonpowered
Device Class
Class I
Regulation Number
890.5125
Review Panel
PM
Submission Type

Other clearances by The Healthcare Group Laboratories, Inc.

  • K850035 — EMPTY SOLUTION TRANSFER CONTAINER (June 7, 1985)
  • K842170 — EMPTY SOLUTION TRANSFER CONTAINER (October 19, 1984)
  • K842091 — DISPOS. ACU-CUT SOFT TISSUE BIOPSY (July 23, 1984)
  • K840742 — RIGHT ATRIAL CATHETER (July 13, 1984)
  • K830299 — SOLUTION TRANSFER CONTAINER (February 19, 1983)
  • K822307 — ADHESIVE SPRAY #4050-4060 (September 24, 1982)
  • K822059 — SHOW'RBAG (July 22, 1982)
  • K821480 — RIGHT ATRIAL CATHETERS PARENTERAL NUTRIT (June 17, 1982)
  • K821230 — SOFTIC 49 (May 28, 1982)
  • K821162 — ADHESIVE REMOVER (May 14, 1982)

Other clearances for product code KTC

  • K912179 — THE SPRITZ BATH (August 28, 1991)
  • K890085 — SIT-N-BATHE SITZ BATH (February 13, 1989)
  • K862600 — SITZ BATH (July 18, 1986)
  • K851309 — ABCO PLASTIC UTENSILS (July 1, 1985)
  • K841711 — MAC LEE SITZ BATH (May 7, 1984)
  • K831762 — SITZ BATH, SINGLE PATIENT USE #8100 (June 24, 1983)

FDA data resources