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510(k) K120783

ABLE-X by Im-Able, Ltd. — Product Code ION

K120783 is an FDA 510(k) premarket notification submitted by Im-Able, Ltd. for the device "ABLE-X". The FDA issued a decision of Substantially Equivalent on June 20, 2012. 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
June 20, 2012
Date Received
March 15, 2012
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

  • 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)
  • K830400 — MADDATRAINER HAND EXERCISER (March 9, 1983)

FDA data resources