The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for Rich-mar Hv Ii Select-a-pulse.
Device ID | K810526 |
510k Number | K810526 |
Device Name: | RICH-MAR HV II SELECT-A-PULSE |
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 | 1981-02-26 |
Decision Date | 1981-04-03 |