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510(k) K880454

AT EASE STRESS PAD by Hospital Specialty Co. — Product Code EYQ

K880454 is an FDA 510(k) premarket notification submitted by Hospital Specialty Co. for the device "AT EASE STRESS PAD". The FDA issued a decision of Substantially Equivalent on June 16, 1988. The device falls under product code EYQ (Garment, Protective, For Incontinence), a Class I device regulated under 21 CFR 876.5920. Hospital Specialty Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1988
Date Received
February 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Garment, Protective, For Incontinence
Device Class
Class I
Regulation Number
876.5920
Review Panel
GU
Submission Type

Other clearances by Hospital Specialty Co.

  • K990861 — WOUND DRESSING/ABD PAD, MODEL #10810 (April 12, 1999)
  • K941099 — CLEAN-SORB (September 30, 1994)
  • K882094 — GARDS DEODORANT SANITARY NAPKIN (September 22, 1988)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)
  • K822242 — SANITARY/OB NAPKINS (September 9, 1982)
  • K822433 — GARDS (UNSCENTED, MENSTRUAL PAD) (August 30, 1982)

Other clearances for product code EYQ

  • K950784 — DRISTAR URINARY INCONTINENCE MANAGEMENT SYSTEM (May 3, 1995)
  • K932310 — KIT PAK INCONTINENT SKIN CARE KIT (June 1, 1994)
  • K903342 — DEODORIZING AND SOUND MUFFLING ANAL PAD (October 23, 1990)
  • K891686 — LIB SYSTEM, BABY/ADULT DIAPER (May 31, 1989)
  • K885185 — INTERA SHIELD AND INTERA UNDERGARMENT (February 8, 1989)
  • K883895 — DRIPRIDE ULTRA INCONTINENT PAD (January 30, 1989)
  • K883894 — DRIPRIDE PROVIDE SLIM (January 30, 1989)
  • K883787 — REUSABLE ADULT INCONTINENT DIAPER (November 7, 1988)
  • K882418 — DRY COMFORT UNDERGARMENT (September 29, 1988)
  • K880455 — AT EASE ADULT DIAPER (April 14, 1988)

FDA data resources