The following data is part of a premarket notification filed by Sunnex, Inc. with the FDA for Accuratecare I & Accuratecare Ii.
| Device ID | K851511 |
| 510k Number | K851511 |
| Device Name: | ACCURATECARE I & ACCURATECARE II |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | SUNNEX, INC. 1382 JARVIS AVE. Elk Grove Village, IL 60007 |
| Contact | Jack Chen |
| Correspondent | Jack Chen SUNNEX, INC. 1382 JARVIS AVE. Elk Grove Village, IL 60007 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-15 |
| Decision Date | 1985-07-01 |