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 |