Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Wrap Accessory Electrodes

K-Number: K210383 · 2021-11-12

ApplicantHi-Dow International, Inc.
Decision Date2021-11-12
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Wrap Accessory Electrodes 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 2021-11-12 under 510(k) number K210383. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrap Accessory Electrodes?

Wrap Accessory Electrodes is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Hi-Dow International, Inc.. The 510(k) number is K210383.

When did Wrap Accessory Electrodes receive FDA 510(k) clearance?

Wrap Accessory Electrodes received FDA 510(k) clearance on 2021-11-12, under 510(k) number K210383.

Who is the listed applicant for Wrap Accessory Electrodes?

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 Wrap Accessory Electrodes?

The FDA product code for Wrap Accessory Electrodes is GXY.

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)K202337Pulsed electromagnetic field wrapK190617Wrap accessory electrodesK163393Hi-Dow Wireless TENS/EMS System (Model HD-5N)

Related Devices (Code: GXY)

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.

K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed EuropeK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.

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.

↑