The following data is part of a premarket notification filed by Henley Intl. with the FDA for Model T11 Fluidotherapy Unit.
| Device ID | K896817 |
| 510k Number | K896817 |
| Device Name: | MODEL T11 FLUIDOTHERAPY UNIT |
| Classification | Unit, Fluidotherapy |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | J Henley,phd |
| Correspondent | J Henley,phd HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | LSB |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-04 |
| Decision Date | 1991-01-18 |