The following data is part of a premarket notification filed by Eight Corners, Inc. with the FDA for Back Massager.
| Device ID | K952043 |
| 510k Number | K952043 |
| Device Name: | BACK MASSAGER |
| Classification | Massager, Therapeutic, Manual |
| Applicant | EIGHT CORNERS, INC. 10 B, AUER COURT East Brunswick, NJ 08816 |
| Contact | Chia-hwa Tao |
| Correspondent | Chia-hwa Tao EIGHT CORNERS, INC. 10 B, AUER COURT East Brunswick, NJ 08816 |
| Product Code | LYG |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-01 |
| Decision Date | 1995-09-01 |