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510(k) K812319

THERAPY BENCH by Kaye Products, Inc. — Product Code IOD

K812319 is an FDA 510(k) premarket notification submitted by Kaye Products, Inc. for the device "THERAPY BENCH". The FDA issued a decision of Substantially Equivalent on August 31, 1981. The device falls under product code IOD (Components, Exercise), a Class I device regulated under 21 CFR 890.5350. Kaye Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
August 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Components, Exercise
Device Class
Class I
Regulation Number
890.5350
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)
  • K812399 — CHAIR, ADJUSTABLE, MECHANICAL (September 14, 1981)
  • K810609 — PEDIATRIC POSITION HOLDER (March 20, 1981)

Other clearances for product code IOD

  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K823648 — SURGICAL TUBING (January 21, 1983)
  • K823822 — ANKLE WEIGHTS (January 14, 1983)
  • K823600 — SOLID WOOD CONE (December 22, 1982)
  • K813632 — COLOR CODED WEIGHT CUFFS (January 19, 1982)
  • K790587 — CANVAS WEDGE (April 3, 1979)
  • K772414 — SANDBAGS, VARIOUS WEIGHTS (February 1, 1978)
  • K771030 — FLEXION MITTENS (June 27, 1977)
  • K761119 — SHEET METAL CLAMP (December 2, 1976)
  • K761118 — HAND SCREW CLAMP (December 2, 1976)

FDA data resources