The following data is part of a premarket notification filed by Jansson A/s with the FDA for Akufon Therapeutic Massager.
| Device ID | K850495 |
| 510k Number | K850495 |
| Device Name: | AKUFON THERAPEUTIC MASSAGER |
| Classification | Vibrator, Therapeutic |
| Applicant | JANSSON A/S KIRKETORVET 18 Vejle, DK |
| Contact | Orum Meier |
| Correspondent | Orum Meier JANSSON A/S KIRKETORVET 18 Vejle, DK |
| Product Code | IRO |
| CFR Regulation Number | 890.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-08 |
| Decision Date | 1986-01-03 |