The following data is part of a premarket notification filed by Helio Medical Supplies, Inc. with the FDA for Acuglide Brand Acupuncture Needles.
| Device ID | K012583 |
| 510k Number | K012583 |
| Device Name: | ACUGLIDE BRAND ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. San Jose, CA 95131 |
| Contact | Yi Fen Chang |
| Correspondent | Yi Fen Chang HELIO MEDICAL SUPPLIES, INC. 606 CHARCOT AVE. San Jose, CA 95131 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-10 |
| Decision Date | 2001-12-11 |