The following data is part of a premarket notification filed by Philco Ushuaia with the FDA for Massaging Helmet C.f. Hansen Design.
| Device ID | K940582 |
| 510k Number | K940582 |
| Device Name: | MASSAGING HELMET C.F. HANSEN DESIGN |
| Classification | Vibrator, Therapeutic |
| Applicant | PHILCO USHUAIA 4881 YONGE STREET, SUITE 602 NORTH YORK, ONTARIO M2N 5X3 CANADA, CA |
| Contact | ROBERTO RIVELA |
| Correspondent | ROBERTO RIVELA PHILCO USHUAIA 4881 YONGE STREET, SUITE 602 NORTH YORK, ONTARIO M2N 5X3 CANADA, CA |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-08 |
| Decision Date | 1995-01-30 |