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510(k) K840551

MOBILIZER by Lossing Orthopedic, Inc. — Product Code ION

K840551 is an FDA 510(k) premarket notification submitted by Lossing Orthopedic, Inc. for the device "MOBILIZER". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code ION (Exerciser, Non-Measuring), a Class I device regulated under 21 CFR 890.5370. Lossing Orthopedic, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 1984
Date Received
February 8, 1984
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 Lossing Orthopedic, Inc.

  • K900475 — DISTRAC(TM) TABLE (May 24, 1990)
  • K864152 — BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE (February 5, 1987)
  • K862874 — THE TOWERED 90/90 UNIT (August 7, 1986)
  • K843581 — PROM NAID (December 11, 1984)
  • K823236 — BACK ON TRACK INVERSION THERAPY & EXER (January 21, 1983)
  • K813017 — NECKTRAC (November 25, 1981)
  • K802555 — COTTRELL 90/90 BACKTRAC (October 31, 1980)

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)
  • 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