The following data is part of a premarket notification filed by Daito Electric Machine Industries Company, Ltd. with the FDA for Oster Massage Wand Stick Massager 295-07.
| Device ID | K850771 |
| 510k Number | K850771 |
| Device Name: | OSTER MASSAGE WAND STICK MASSAGER 295-07 |
| Classification | Massager, Therapeutic, Electric |
| Applicant | DAITO ELECTRIC MACHINE INDUSTRIES COMPANY, LTD. OSTER 5055 N. LYDELL AVENUE Milwaukee, WI 53217 |
| Contact | Janice A Karr |
| Correspondent | Janice A Karr DAITO ELECTRIC MACHINE INDUSTRIES COMPANY, LTD. OSTER 5055 N. LYDELL AVENUE Milwaukee, WI 53217 |
| Product Code | ISA |
| CFR Regulation Number | 890.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-25 |
| Decision Date | 1985-05-14 |