The following data is part of a premarket notification filed by Henley Intl. with the FDA for Vasotrain 447.
| Device ID | K871107 |
| 510k Number | K871107 |
| Device Name: | VASOTRAIN 447 |
| Classification | Vibrator, Therapeutic |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Henley, Dr |
| Correspondent | Henley, Dr HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| 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 | 1987-03-19 |
| Decision Date | 1987-05-29 |