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510(k) K760509

TREADMILL, DIAGNOSTIC by Medcraft Corp. — Product Code IOL

K760509 is an FDA 510(k) premarket notification submitted by Medcraft Corp. for the device "TREADMILL, DIAGNOSTIC". The FDA issued a decision of Substantially Equivalent on August 30, 1976. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Medcraft Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1976
Date Received
August 24, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Treadmill, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Medcraft Corp.

  • K860467 — ELECTROSHOCK UNIT NEUROLOGY MODEL B-25 (November 10, 1986)
  • K791795 — COMP-ACT IV (September 27, 1979)
  • K760508 — ACCUTAPE 24 (August 30, 1976)
  • K760510 — MONITORING SYSTEM, REHABILITATION (August 30, 1976)

Other clearances for product code IOL

  • K950376 — PARKER MODEL PM (September 6, 1995)
  • K950377 — PARKER MODEL PE (September 6, 1995)
  • K925839 — TRACKMASTER (June 24, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K904556 — MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB (December 18, 1991)
  • K913518 — TA620 TREADMILL CONTROLLER (October 24, 1991)
  • K910867 — T600 TREADMILL (May 31, 1991)
  • K911751 — MEDTRACK TREADMILL (May 29, 1991)
  • K897179 — ORBITER(TM) TREADMILL (February 15, 1990)
  • K895104 — AQUATREX UNDERWATER TREADMILL SYSTEM (December 4, 1989)

FDA data resources