The following data is part of a premarket notification filed by Everlife Medical Equipment Co., Ltd. with the FDA for Everelife Transcutaneous Muscle Stimulator.
| Device ID | K071624 |
| 510k Number | K071624 |
| Device Name: | EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EVERLIFE MEDICAL EQUIPMENT CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min EVERLIFE MEDICAL EQUIPMENT CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-14 |
| Decision Date | 2007-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858688006308 | K071624 | 000 |
| 00858688006292 | K071624 | 000 |
| 00851610008326 | K071624 | 000 |
| 10851610008347 | K071624 | 000 |