The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Lifecare Arm & Leg Pain Relief System.
| Device ID | K112415 |
| 510k Number | K112415 |
| Device Name: | LIFECARE ARM & LEG PAIN RELIEF SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3FL. NO.5 LANE 155, SEC 3 PEISHEN RD, SHENKENG HSIANG Taipei Hsien, TW 222 |
| Contact | Robert Tu |
| Correspondent | Robert Tu EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 3FL. NO.5 LANE 155, SEC 3 PEISHEN RD, SHENKENG HSIANG Taipei Hsien, TW 222 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-22 |
| Decision Date | 2011-10-21 |
| Summary: | summary |