The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rm Vi-hv.
Device ID | K771157 |
510k Number | K771157 |
Device Name: | RM VI-HV |
Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
Applicant | RICH-MAR CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | IMG |
CFR Regulation Number | 890.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-06-28 |
Decision Date | 1977-07-21 |