The following data is part of a premarket notification filed by Rs Medical with the FDA for Rs-4i Muscle Stimulator Family.
Device ID | K062325 |
510k Number | K062325 |
Device Name: | RS-4I MUSCLE STIMULATOR FAMILY |
Classification | Stimulator, Electrical, Transcutaneous, For Arthritis |
Applicant | RS MEDICAL P.O. BOX 3515 Redmond, WA 98073 |
Contact | Steven Chernoff |
Correspondent | Steven Chernoff RS MEDICAL P.O. BOX 3515 Redmond, WA 98073 |
Product Code | NYN |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-09 |
Decision Date | 2007-04-13 |
Summary: | summary |