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510(k) K812399

CHAIR, ADJUSTABLE, MECHANICAL by Kaye Products, Inc. — Product Code INN

K812399 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "CHAIR, ADJUSTABLE, MECHANICAL". The FDA issued a decision of Substantially Equivalent on September 14, 1981. The device falls under product code INN (Chair, Adjustable, Mechanical), 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
September 14, 1981
Date Received
August 20, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Adjustable, Mechanical
Device Class
Class I
Regulation Number
890.3100
Review Panel
PM
Submission Type

Other clearances by Kaye Products, Inc.

  • K924848 — KAYE SCOOT-ABOUT, MODEL SB1 (February 12, 1993)
  • 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)
  • K812319 — THERAPY BENCH (August 31, 1981)
  • K810609 — PEDIATRIC POSITION HOLDER (March 20, 1981)

Other clearances for product code INN

  • K945650 — SPIFFY (December 19, 1994)
  • K942397 — THERADAPT HIGHCHAIR/STROLLER INSERT (June 22, 1994)
  • K930520 — THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (March 24, 1993)
  • K923750 — ABLE GENERATION BOOSTER CHAIR (January 29, 1993)
  • K923752 — ABLE GENERATION PLAY CHAIR (January 29, 1993)
  • K923753 — ABLE GENERATION THERAPY TILT BENCH (January 29, 1993)
  • K923095 — KAYE MODEL KIAO PELVIC/THIGH STABILIZER (July 21, 1992)
  • K922061 — CHAIR, ADJUSTABLE, MECHANICAL (May 26, 1992)
  • K921272 — ACTIVITY CHAIR (April 7, 1992)
  • K904069 — BRODA NURSING CARE CHAIR (September 17, 1990)

FDA data resources