510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800958Substantially Equivalent

Personal Sitz Bath Kit

The Healthcare Group Laboratories, Inc., MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800958 is the FDA 510(k) clearance record for PERSONAL SITZ BATH KIT, a class I device, cleared for The Healthcare Group Laboratories, Inc. on under FDA product code KTC (Bath, Sitz, Nonpowered). FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from to . As of , FDA records show no recalls naming K800958.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KTC Bath, Sitz, Nonpowered
Regulation
21 CFR 890.5125
Device class
Class I
Review panel
Physical Medicine
Applicant
The Healthcare Group Laboratories, Inc.
Third party review
No

Clearances, product code KTC

Trailing 12 months

FDA records hold no clearances under product code KTC in the trailing twelve months.

FDA records show no clearances under product code KTC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260