The following data is part of a premarket notification filed by Electromed Corp. with the FDA for Rehcor.
Device ID | K990813 |
510k Number | K990813 |
Device Name: | REHCOR |
Classification | Exerciser, Measuring |
Applicant | ELECTROMED CORP. PO 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm ELECTROMED CORP. PO 7007 Deerfield, IL 60015 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-11 |
Decision Date | 1999-04-12 |
Summary: | summary |