The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Bmr Neurotech Back Tens And Lumbar Support Device. Type 294.
Device ID | K023916 |
510k Number | K023916 |
Device Name: | BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
Contact | Michelle Sawyer |
Correspondent | Michelle Sawyer BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, West Galway, IE |
Product Code | GZJ |
Subsequent Product Code | GXY |
Subsequent Product Code | IQE |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-11-25 |
Decision Date | 2004-04-15 |
Summary: | summary |