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510(k) K851630

TMX-80 TREADMILL by Eaton Medical Group — Product Code IOL

K851630 is an FDA 510(k) premarket notification submitted by Eaton Medical Group for the device "TMX-80 TREADMILL". The FDA issued a decision of Substantially Equivalent on July 9, 1985. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Eaton Medical Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1985
Date Received
April 18, 1985
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 Eaton Medical Group

  • K851623 — MODEL TRC-40 TELEMETRY RECIEVER MODULE (January 22, 1986)
  • K851624 — MODEL TT-185 TELEMETRY TRANSMITTER (January 14, 1986)
  • K851625 — SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (November 19, 1985)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K851632 — PCX-100 PATIENT INPUT LEADWIRE (November 8, 1985)
  • K851631 — TMX-C1/C2 TRADMILL CONTROLLER ACCESS. (July 15, 1985)
  • K851629 — TMX-70 TREADMILL (July 9, 1985)
  • K851628 — RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO (June 27, 1985)
  • K851633 — CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL (June 26, 1985)
  • K851626 — SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE (June 26, 1985)

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