The following data is part of a premarket notification filed by Rich-mar Corp. with the FDA for If2000 Electrical Muscle Stimulator Unit.
Device ID | K893994 |
510k Number | K893994 |
Device Name: | IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT |
Classification | Stimulator, Muscle, Powered |
Applicant | RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
Contact | David Richards |
Correspondent | David Richards RICH-MAR CORP. P.O. BOX 879 Inola, OK 74036 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-05 |
Decision Date | 1989-12-14 |