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FDA 510(k)

HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL

K-Number: K072256 · 2008-03-12

ApplicantHill Laboratories Co.
Decision Date2008-03-12
Product CodePFW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Hill Laboratories Co.. It received FDA 510(k) clearance on 2008-03-12 under 510(k) number K072256. The device is classified under product code PFW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL?

HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL is a medical device that received FDA 510(k) clearance on 2008-03-12. The listed applicant is Hill Laboratories Co.. The 510(k) number is K072256.

When did HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL receive FDA 510(k) clearance?

HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL received FDA 510(k) clearance on 2008-03-12, under 510(k) number K072256.

Who is the listed applicant for HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL?

The FDA 510(k) record lists Hill Laboratories Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL?

The FDA product code for HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL is PFW.

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Other records listing Hill Laboratories Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090250ELECTRO-LIGHT THERAPYK083183AKLARUS PHOTOTHERAPY SYSTEMK062256HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEMK063034AIR-FLEX WITH AUTO-DISTRACTIONK043239HEALTHSTAR ELITEK952357THE HILL ADJUSTABLE PODIATRY MODEL

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Related Devices (Code: PFW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260076SAM 3.0 Multi-Hour Continuous Ultrasound DeviceZetrOZ Systems, LLCK233210sam CS Long Duration Ultrasound DeviceZetrOZ Systems, LLCK223019sam 2.0 Long Ultrasound DeviceZetrOZ Systems, LLCK221210PainShield MD PLUSNanovibronix, Inc.K211513sam X1 Long Duration Ultrasound DeviceZetrOZ Systems, LLCK191568sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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