The following data is part of a premarket notification filed by Hontech Foundation For Medical Technology with the FDA for Li's Itch Stopper.
| Device ID | K963824 |
| 510k Number | K963824 |
| Device Name: | LI'S ITCH STOPPER |
| Classification | Pad, Heating, Powered |
| Applicant | HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY 402 RINDGE AVE., STE. 17H Cambridge, MA 02140 |
| Contact | Huan-chen Li |
| Correspondent | Huan-chen Li HONTECH FOUNDATION FOR MEDICAL TECHNOLOGY 402 RINDGE AVE., STE. 17H Cambridge, MA 02140 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-23 |
| Decision Date | 1996-12-12 |