The following data is part of a premarket notification filed by Helio Medical Supplies, Inc. with the FDA for Ea Stimulator.
| Device ID | K080221 |
| 510k Number | K080221 |
| Device Name: | EA STIMULATOR |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. San Jose, CA 95131 |
| Contact | Yukuo Hso |
| Correspondent | Yukuo Hso HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. San Jose, CA 95131 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-29 |
| Decision Date | 2008-09-09 |
| Summary: | summary |