Nimbl (model PD08-N1)

FDA 510(k) K234155 · Tactile Medical

Substantially Equivalent

510(k) numberK234155

Submission

Device name
Nimbl (model PD08-N1)
Applicant
Tactile Medical
Minneapolis, MN, US
Received
December 29, 2023
Decision date
June 21, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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K254217AerloomJOW · Traditional Evolym, LLC08/31/2026SE
K253555Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional Tactile Medical07/31/2026SE
K253386DVT GarmentJOW · Traditional Vistar Medical Supplies Co., Ltd.06/25/2026SE
K250242Compression Therapy Device (LGT-2202DVT)JOW · Traditional Guangzhou Longest Medical Technology Co., Ltd.04/24/2026SE
K254267NanoPress 760A-BT (760A-BT)JOW · Traditional Mego Afek , Ltd.02/24/2026SE
K250974Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional Bio Compression Systems, Inc.12/12/2025SE
K250190Sequential Compression System (SCD600)JOW · Traditional Shenzhen Comen Medical Instruments Co.,Ltd12/08/2025SE
K251466VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special Wellell, Inc.10/28/2025SE
K251446PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special Manamed, LLC09/17/2025SE

More from Manamed, LLC

510(k)DeviceDecision
K253555Flexitouch® Plus Advanced Pneumatic Compression SystemJOW · Traditional 07/31/2026SE
K252849AffloVest® Mobile Airway Clearance TherapyBYI · Traditional 04/30/2026SE

Questions and answers

When was Nimbl (model PD08-N1) cleared by the FDA?

Nimbl (model PD08-N1) (K234155) received a 510(k) decision of Substantially Equivalent on June 21, 2024, 175 days after the submission was received.

What is the product code of K234155?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.