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510(k) K885343

STANDEX by Alt, Inc. — Product Code ION

K885343 is an FDA 510(k) premarket notification submitted by Alt, Inc. for the device "STANDEX". The FDA issued a decision of Substantially Equivalent on May 1, 1989. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1989
Date Received
December 28, 1988
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 for product code ION

  • K120783 — ABLE-X (June 20, 2012)
  • 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)
  • K830400 — MADDATRAINER HAND EXERCISER (March 9, 1983)

FDA data resources