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510(k) K830560

EXERCISER, PASSIVE, NON MEASURING by Kaye Products, Inc. — Product Code ION

K830560 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "EXERCISER, PASSIVE, NON MEASURING". The FDA issued a decision of Substantially Equivalent on March 9, 1983. The device falls under product code ION (Exerciser, Non-Measuring), 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 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Non-Measuring
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)
  • 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 ION

  • K120783 — ABLE-X (June 20, 2012)
  • K885343 — STANDEX (May 1, 1989)
  • K851065 — GRAVITY KING (DEEMED SE 87/09/18) (June 13, 1985)
  • K840551 — MOBILIZER (March 23, 1984)
  • K833870 — KNEE WALKER (November 29, 1983)
  • K833249 — FITNESS (November 7, 1983)
  • K832968 — PEDAL EXERCISER (September 29, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831538 — DELUXE ADJUST-ANGLE BOARD-BK4066 (June 8, 1983)
  • K831033 — GIREX (April 27, 1983)

FDA data resources