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510(k) K931555

ARTROMOT K2 CPM by Ormed Mfg., Inc. — Product Code BXB

K931555 is an FDA 510(k) premarket notification submitted by Ormed Mfg., Inc. for the device "ARTROMOT K2 CPM". The FDA issued a decision of Substantially Equivalent on January 31, 1994. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Ormed Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 1994
Date Received
March 30, 1993
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 Ormed Mfg., Inc.

  • K882527 — GAUZE SPONGE (July 18, 1988)
  • K882528 — CYLINDRICAL SPONGE (July 18, 1988)
  • K882529 — BUTCHER STRUNG TONSIL SPONGE (July 18, 1988)
  • K882530 — TAPE STRUNG TONSIL SPONGE (July 18, 1988)
  • K880911 — BLUNT SPONGE (March 17, 1988)
  • K880852 — ROSEBUD DISSECTORS (March 17, 1988)
  • K880907 — TRIANGLE SPONGE (March 17, 1988)
  • K880909 — TRACHEOTOMY SPONGES (March 17, 1988)
  • K880853 — CHERRY SPONGE (March 17, 1988)
  • K880910 — ROUND STICK SPONGES (March 17, 1988)

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)
  • K955105 — BTE CPM-10 (December 29, 1995)
  • K955106 — BTE CPM-20 (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