Home / 510(k) Clearances / K925666

510(k) K925666

THERAPACER 3000 by Kvm Technologies, Inc. — Product Code BXB

K925666 is an FDA 510(k) premarket notification submitted by Kvm Technologies, Inc. for the device "THERAPACER 3000". The FDA issued a decision of Substantially Equivalent on March 9, 1993. The device falls under product code BXB (Exerciser, Powered), a Class I device regulated under 21 CFR 890.5380. Kvm Technologies, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1993
Date Received
November 10, 1992
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 Kvm Technologies, Inc.

  • K883990 — KVM ISOTONIC DILUENT (October 12, 1988)
  • K883989 — KVM ISOTONIC FLUSH SOLUTION (October 12, 1988)
  • K883992 — KVM PREPACK HEMATOLOGY REAGENT SET (October 12, 1988)
  • K883991 — KVM HEMOGLOBIN LYSING REAGENT (October 12, 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)
  • 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