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510(k) K990813

REHCOR by Electromed Corp. — Product Code ISD

K990813 is an FDA 510(k) premarket notification submitted by Electromed Corp. for the device "REHCOR". The FDA issued a decision of Substantially Equivalent on April 12, 1999. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360. Electromed Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1999
Date Received
March 11, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

Other clearances by Electromed Corp.

  • K222496 — Electromed SmartVest Airway Clearance System (November 18, 2022)
  • K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEM (December 19, 2013)
  • K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (December 1, 2005)
  • K040367 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (April 7, 2004)
  • K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 (June 1, 1999)

Other clearances for product code ISD

  • K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Do (December 21, 2020)
  • K183296 — REAL Immersive System (March 18, 2019)
  • K143512 — ActiSpec Activity Monitor (August 26, 2015)
  • K112121 — ERGOSELECT/GE (October 31, 2012)
  • K080545 — ACTITRAINER (July 24, 2008)
  • K053078 — ERGOSELECT 100 K/P, ERGOSELECT 200 K/P (April 27, 2006)
  • K990866 — QUINTON MEDTRACK CR PLUS TREADMILL (April 29, 1999)
  • K962855 — ULE-2, MULE-2, HAND ACCESSORY KIT (December 11, 1996)
  • K952163 — DAVID BACK CLINIC SYSTEM (August 12, 1996)
  • K941033 — PHYSIO HAB (February 27, 1995)

FDA data resources