The following data is part of a premarket notification filed by Henley Intl. with the FDA for Model K210 And K211 Fluidotherapy Units.
| Device ID | K871802 |
| 510k Number | K871802 |
| Device Name: | MODEL K210 AND K211 FLUIDOTHERAPY UNITS |
| Classification | Unit, Fluidotherapy |
| Applicant | HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Contact | Ernest J Henley,phd |
| Correspondent | Ernest J Henley,phd HENLEY INTL. 10518 KINGHURST Houston, TX 77099 |
| Product Code | LSB |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-08 |
| Decision Date | 1987-09-04 |