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.
| Device ID | K062256 |
| 510k Number | K062256 |
| Device Name: | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | HILL LABORATORIES CO. 3 BACTON HILL RD. Frazer, PA 19355 |
| Contact | Brandy Alter |
| Correspondent | Brandy Alter HILL LABORATORIES CO. 3 BACTON HILL RD. Frazer, PA 19355 |
| Product Code | IMI |
| 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 | 2006-08-04 |
| Decision Date | 2007-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001452532 | K062256 | 000 |