REHCOR— 510(k) K990813

Name: FDA 510(k) clearance K990813
Creator: U.S. Food and Drug Administration
Published: 1999-04-12

Substantially Equivalent

Electromed Corp.

FDA 510(k) clearance K990813 for REHCOR, Substantially Equivalent on 1999-04-12. Applicant: Electromed Corp.. Device class: 2.

Clearance details

Applicant: Electromed Corp.
Product code: Code ISD
Device class: Class 2
Regulation: 21 CFR 890.5360
Advisory panel: Physical Medicine
Date received: 1999-03-11
Decision date: 1999-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISD

view all

K202979 — MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra2020-12-21
K183296 — REAL Immersive System2019-03-18
K143512 — ActiSpec Activity Monitor2015-08-26
K112121 — ERGOSELECT/GE2012-10-31
K080545 — ACTITRAINER2008-07-24

Adverse events under product code ISD

product code ISD

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.