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510(k) K924848

KAYE SCOOT-ABOUT, MODEL SB1 by Kaye Products, Inc. — Product Code INM

K924848 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "KAYE SCOOT-ABOUT, MODEL SB1". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Kaye Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
September 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, With Casters
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Kaye Products, Inc.

  • K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZER (July 21, 1992)
  • K922061 — CHAIR, ADJUSTABLE, MECHANICAL (May 26, 1992)
  • K885330 — WHEELCHAIR, MECHANICAL (February 3, 1989)
  • K833869 — CHILD'S WALKER (November 29, 1983)
  • K830560 — EXERCISER, PASSIVE, NON MEASURING (March 9, 1983)
  • K830466 — BARS, PARALLEL, EXERCISE (March 9, 1983)
  • K820591 — MECHANICAL CHAIR (March 15, 1982)
  • K812399 — CHAIR, ADJUSTABLE, MECHANICAL (September 14, 1981)
  • K812319 — THERAPY BENCH (August 31, 1981)
  • K810609 — PEDIATRIC POSITION HOLDER (March 20, 1981)

Other clearances for product code INM

  • K063521 — NISSIN PEDIATRIC SERIES WHEELCHAIR (February 5, 2007)
  • K941738 — STRYKER 5050 STRECHAIR (May 6, 1994)
  • K941569 — CAREMOR CLINER (April 26, 1994)
  • K933000 — RECLINING GERI CHAIRS W/CASTERS & LAP TRAY (September 30, 1993)
  • K926028 — BENCHES (March 24, 1993)
  • K926053 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K926025 — CHAIRS (March 22, 1993)
  • K926054 — ELD-ARONDAK CHAIR (March 22, 1993)
  • K925247 — STONEHEART ROLLER AID (February 12, 1993)
  • K922045 — SHOWER CHAIRS (May 26, 1992)

FDA data resources