The following data is part of a premarket notification filed by Henley Intl. with the FDA for Dynatron 438.
| Device ID | K870515 |
| 510k Number | K870515 |
| Device Name: | DYNATRON 438 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Peter M Graham |
| Correspondent | Peter M Graham HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-05 |
| Decision Date | 1987-06-16 |