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FDA 510(k)

Pulsed electromagnetic field wrap

K-Number: K202337 · 2020-12-15

ApplicantHi-Dow International, Inc.
Decision Date2020-12-15
Product CodeILX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Pulsed electromagnetic field wrap is a medical device manufactured by Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2020-12-15 under approval number K202337. The device is classified under product code ILX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Pulsed electromagnetic field wrap?

Pulsed electromagnetic field wrap is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by Hi-Dow International, Inc.. The 510(k) number is K202337.

When was Pulsed electromagnetic field wrap approved by the FDA?

Pulsed electromagnetic field wrap received FDA 510(k) clearance on 2020-12-15, under approval number K202337.

What company makes Pulsed electromagnetic field wrap?

Pulsed electromagnetic field wrap is manufactured by Hi-Dow International, Inc..

What is the FDA product code for Pulsed electromagnetic field wrap?

The FDA product code for Pulsed electromagnetic field wrap is ILX.

Related Clinical Trials

NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT07187115 A Global Study Comparing Pulsed Field Ablation With Electrographic Flow Mapping Versus Posterior Wall Ablation for Persistent Atrial Fibrillation RECRUITING NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT07601763 Pulsed Field Ablation Outcomes With Efficacy and Randomization in Atrial Fibrillation (POWER-AF) RECRUITING NCT06735534 Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System RECRUITING NCT07610018 Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems NOT_YET_RECRUITING

Other Devices by Hi-Dow International, Inc.

K163393Hi-Dow Wireless TENS/EMS System (Model HD-5N) K190617Wrap accessory electrodes K210383Wrap Accessory Electrodes K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)

Related Devices (Code: ILX)

K190251RecoveryRxBioelectronics Corporation K241395Active System; Avenue8Caerus Corporation

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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