K040253 is an FDA 510(k) clearance for the EASY MED TN-28 C. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Easy Med Instrument Co., Ltd. (Guangdong, CN). The FDA issued a Cleared decision on April 8, 2004, 64 days after receiving the submission on February 4, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K040253 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2004 |
| Decision Date | April 08, 2004 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |