The following data is part of a premarket notification filed by Micro Current Technology, Inc. with the FDA for S21 Transcutaneous Electrical Nerve Stimulator.
Device ID | K033253 |
510k Number | K033253 |
Device Name: | S21 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | MICRO CURRENT TECHNOLOGY, INC. 4822 CALIFORNIA AVE., S.W. Seattle, WA 98116 |
Contact | David Suzuki |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-10-08 |
Decision Date | 2003-10-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817076010860 | K033253 | 000 |
00817076010846 | K033253 | 000 |
00817076010839 | K033253 | 000 |