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510(k) K894907

MARK IV HAND, THUMB AND WRIST (CPM) UNIT by Innovative Medical Engineering, Inc. — Product Code BXB

K894907 is an FDA 510(k) premarket notification submitted by Innovative Medical Engineering, Inc. for the device "MARK IV HAND, THUMB AND WRIST (CPM) UNIT". The FDA issued a decision of Substantially Equivalent on October 6, 1989. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Innovative Medical Engineering, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 6, 1989
Date Received
August 1, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Innovative Medical Engineering, Inc.

  • K902600 — THE COMPANION NON-ELECTRIC LIFT CHAIR (June 21, 1990)

Other clearances for product code BXB

  • K072887 — G-TRAINER MEDICAL (January 25, 2008)
  • K003272 — FLO-BOOT (April 4, 2001)
  • K952975 — ANKLE CALF EXERCISER PHLEBOPUMP (September 25, 1996)
  • K953456 — E-Z FLEX (January 26, 1996)
  • K955106 — BTE CPM-20 (December 29, 1995)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K951028 — HAMEX TWO (December 11, 1995)
  • K950755 — FLEXMATE K500 (October 5, 1995)
  • K951029 — HAMEX ONE (September 15, 1995)
  • K945733 — AQUAHAB, MODEL 120-72-101 (September 15, 1995)

FDA data resources