The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Tens For Low Back Pain Relief, Model Wl-2405 And Wl-2406.
| Device ID | K052785 |
| 510k Number | K052785 |
| Device Name: | OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 5 FL., STE 504,EMPIRE CENTRE 68 MODY ROAD, TSIMSHATSUIM Kowloon, HK |
| Contact | Grace Chang |
| Correspondent | Grace Chang WELL-LIFE HEALTHCARE LIMITED 5 FL., STE 504,EMPIRE CENTRE 68 MODY ROAD, TSIMSHATSUIM Kowloon, HK |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-03 |
| Decision Date | 2006-03-17 |
| Summary: | summary |