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510(k) K820591

MECHANICAL CHAIR by Kaye Products, Inc. — Product Code LBE

K820591 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "MECHANICAL CHAIR". The FDA issued a decision of Substantially Equivalent on March 15, 1982. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850. Kaye Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1982
Date Received
March 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stroller, Adaptive
Device Class
Class I
Regulation Number
890.3850
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)
  • 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 LBE

  • K223533 — Little Wave Arc; Little Wave Flip (August 31, 2023)
  • K130644 — PEDIATRIC FOLDING WHEELCHAIR (October 16, 2013)
  • K863450 — SULKY SPECIAL (October 23, 1986)
  • K862888 — PERAMBULATOR (STROLLER) (August 13, 1986)
  • K840250 — CARRIER (February 9, 1984)
  • K810676 — CONVAID CRUISER CP4M (March 26, 1981)
  • K781947 — STROLLER, THERAPY (December 4, 1978)

FDA data resources