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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 the device name listed in this FDA 510(k) record. The listed applicant is Hi-Dow International, Inc.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) 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. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K202337.

When did Pulsed electromagnetic field wrap receive FDA 510(k) clearance?

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

Who is the listed applicant for Pulsed electromagnetic field wrap?

The FDA 510(k) record lists Hi-Dow International, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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Other records listing Hi-Dow International, Inc. 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.

K233461Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A)K210383Wrap Accessory ElectrodesK190617Wrap accessory electrodesK163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Related Devices (Code: ILX)

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.

K241395Active System; Avenue8Caerus CorporationK190251RecoveryRxBioelectronics Corporation

Official Source

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

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