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510(k) K830466

BARS, PARALLEL, EXERCISE by Kaye Products, Inc. — Product Code IOE

K830466 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "BARS, PARALLEL, EXERCISE". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code IOE (Bars, Parallel, Exercise), a Class I device regulated under 21 CFR 890.5370. Kaye Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1983
Date Received
February 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bars, Parallel, Exercise
Device Class
Class I
Regulation Number
890.5370
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)
  • 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 IOE

  • K770611 — PARALLEL BARS (April 8, 1977)

FDA data resources