The following data is part of a premarket notification filed by Hill Laboratories Co. with the FDA for Hf54 Combination Ultrasound Interferential And Premodulated Stimulation System With Optional Hands-free Operation, Model.
| Device ID | K072256 |
| 510k Number | K072256 |
| Device Name: | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL |
| Classification | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Applicant | HILL LABORATORIES CO. 3 N. BACTON HILL RD. Frazer, PA 19355 |
| Contact | Brady Aller |
| Correspondent | Brady Aller HILL LABORATORIES CO. 3 N. BACTON HILL RD. Frazer, PA 19355 |
| Product Code | PFW |
| Subsequent Product Code | ILY |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-13 |
| Decision Date | 2008-03-12 |
| Summary: | summary |