The following data is part of a premarket notification filed by Health Ent., Inc. with the FDA for Acu-strap Motion Sickness Band.
| Device ID | K041877 |
| 510k Number | K041877 |
| Device Name: | ACU-STRAP MOTION SICKNESS BAND |
| Classification | Device, Acupressure |
| Applicant | HEALTH ENT., INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Daniel J Dillon |
| Correspondent | Daniel J Dillon HEALTH ENT., INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | MVV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-12 |
| Decision Date | 2004-10-08 |
| Summary: | summary |