The following data is part of a premarket notification filed by Easymed Instrument Co., Ltd. with the FDA for Easy Med Tn-28 C.
| Device ID | K040253 |
| 510k Number | K040253 |
| Device Name: | EASY MED TN-28 C |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EASYMED INSTRUMENT CO., LTD. 2/F-3/F, NO.2 BEIHAI DA ROAD LUNJIAO, SHUNDE Guangdong, CN 528303 |
| Contact | Wu Tingjie |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-04 |
| Decision Date | 2004-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869911592802 | K040253 | 000 |