The following data is part of a premarket notification filed by Everlife Medical Equipment Co., Ltd. with the FDA for Everlife Powered Muscle Stimulator, Model E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311.
| Device ID | K071320 |
| 510k Number | K071320 |
| Device Name: | EVERLIFE POWERED MUSCLE STIMULATOR, MODEL E-100204, E-100504, E-100509, E-100804, E-201111, E-201211, E-201311 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EVERLIFE MEDICAL EQUIPMENT CO., LTD. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min EVERLIFE MEDICAL EQUIPMENT CO., LTD. NO. 58, FU-CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-10 |
| Decision Date | 2007-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858688006254 | K071320 | 000 |