The following data is part of a premarket notification filed by Medical Equipment Device Specialists with the FDA for Meds-4 Neuromuscular Stimulator.
Device ID | K023435 |
510k Number | K023435 |
Device Name: | MEDS-4 NEUROMUSCULAR STIMULATOR |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MEDICAL EQUIPMENT DEVICE SPECIALISTS 32158 CAMINO CAPISTRANO SUITE A-416 San Juan Capistrano, CA 92675 |
Contact | C. A. Teklinski |
Correspondent | C. A. Teklinski MEDICAL EQUIPMENT DEVICE SPECIALISTS 32158 CAMINO CAPISTRANO SUITE A-416 San Juan Capistrano, CA 92675 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-15 |
Decision Date | 2003-01-13 |