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FDA 510(k)

Nimbl (model PD08-N1)

K-Number: K234155 · 2024-06-21

ApplicantTactile Medical
Decision Date2024-06-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nimbl (model PD08-N1) is the device name listed in this FDA 510(k) record. The listed applicant is Tactile Medical. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K234155. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nimbl (model PD08-N1)?

Nimbl (model PD08-N1) is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Tactile Medical. The 510(k) number is K234155.

When did Nimbl (model PD08-N1) receive FDA 510(k) clearance?

Nimbl (model PD08-N1) received FDA 510(k) clearance on 2024-06-21, under 510(k) number K234155.

Who is the listed applicant for Nimbl (model PD08-N1)?

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

What is the FDA product code for Nimbl (model PD08-N1)?

The FDA product code for Nimbl (model PD08-N1) is JOW.

Related Clinical Trials

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Other records listing Tactile Medical 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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemK252849AffloVest® Mobile Airway Clearance Therapy

Related Devices (Code: JOW)

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.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments 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.

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