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510(k) K950376

PARKER MODEL PM by Parker Treadmill Co., Inc. — Product Code IOL

K950376 is an FDA 510(k) premarket notification submitted by Parker Treadmill Co., Inc. for the device "PARKER MODEL PM". The FDA issued a decision of Substantially Equivalent on September 6, 1995. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Parker Treadmill Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1995
Date Received
January 31, 1995
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 Parker Treadmill Co., Inc.

  • K950377 — PARKER MODEL PE (September 6, 1995)

Other clearances for product code IOL

  • 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)
  • K893032 — PACER R 9 TREADMILL (July 27, 1989)

FDA data resources