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Decompression of Choice and Neuro Decompression Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101889

by Pivotal Health Solutions

Identifiers

510(k) Number
K101889 FDA 510(k)
FDA Product Code
ITH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5900 FDA 510(k)
Regulation Number
890.5900 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Powered Traction Equipment (FDA classification II) designed to apply controlled decompression forces to intervertebral discs. It is intended for spinal decompression procedures, including axial traction to relieve pressure on spinal structures, as classified under the FDA’s Physical Medicine category.

The Decompression of Choice and Neuro Decompression Device is supplied as a reusable medical instrument, intended for use in clinical settings such as physical medicine and rehabilitation. It operates under FDA clearance via a 510(k) submission (K101889), adhering to regulatory standards outlined in 21 CFR 890.5900. No specific sterility or MRI safety information is provided in the regulatory data. The device is available in multiple configurations, as indicated by the associated registration numbers.

Frequently asked questions

What types of clinical settings is this decompression device intended for use in?

This device is designed for clinical settings focused on physical medicine and rehabilitation, such as outpatient clinics, physical therapy centers, or specialized spinal care facilities. It is classified as Powered Traction Equipment under the FDA’s Physical Medicine category, making it suitable for controlled decompression procedures in these environments.

Is this device single-use or reusable, and what does that mean for maintenance?

The device is explicitly labeled as a reusable medical instrument, meaning it is intended for repeated use across multiple patients after proper cleaning, disinfection, and maintenance. Since it is not sterile, it must be processed according to facility protocols for reusable medical equipment to ensure safety and functionality between uses.

How many configurations or models of this decompression device are available?

The device comes in multiple configurations, as evidenced by the 18 distinct registration numbers listed in the regulatory data (e.g., 3007278668, 3008816697, etc.). These likely correspond to variations in size, traction force settings, or patient positioning systems, allowing for customization to different clinical needs.

What regulatory pathway was followed for FDA clearance, and what does that mean for buyers?

The device received FDA clearance through a Traditional 510(k) pathway (K101889) under the Physical Medicine advisory committee, with a decision of *Substantially Equivalent* to a predicate device. This means the manufacturer demonstrated that the device is as safe and effective as a previously cleared comparable product, adhering to 21 CFR 890.5900. Buyers can rely on this classification for compliance with FDA standards.

Are there any special storage requirements for this device beyond standard medical equipment?

The regulatory data does not specify unique storage requirements beyond what is typical for reusable medical devices. However, since it is not described as sterile or MRI-safe, buyers should store it in a clean, dry environment protected from physical damage and contamination. Follow manufacturer guidelines for any additional care instructions provided with the device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Decompression of Choice and Neuro Decompression Device, Decompression of Choice and Neuro Decompression Device, MAUDE Adverse Event Report: PIVOTAL HEALTH SOLUTIONS DECOMPRESSION OF ..., MAUDE Adverse Event Report: PIVOTAL HEALTH SOLUTIONS, INC DECOMPRESSION ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pivotal Health Solutions

Sources (1)

  • FDA 510(k) K101889 24 fields · synced Oct 6, 2026