← Back to catalogue

First Choice & First Choice Plus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022076

by Body Clock Health Care, Ltd.

Identifiers

510(k) Number
K022076 FDA 510(k)
FDA Product Code
GZJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The First Choice and First Choice Plus are transcutaneous nerve stimulators designed for pain relief. These devices function as nerve stimulators to provide therapeutic electrical stimulation.

This device is identified under FDA 510(k) number K022076 and is classified under regulation 882.5890. It is categorized within the neurology medical specialty and has received a decision of substantially equivalent.

Frequently asked questions

What is the primary function of the First Choice and First Choice Plus devices?

These devices are transcutaneous nerve stimulators designed to provide therapeutic electrical stimulation for the purpose of pain relief.

What is the regulatory status of these nerve stimulators?

The First Choice and First Choice Plus devices have received a decision of substantially equivalent under FDA 510(k) number K022076, falling under the neurology medical specialty.

Who is the manufacturer of the First Choice nerve stimulator line?

The devices are manufactured by Body Clock Health Care, Ltd., which is based in London, England.

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: FIRST CHOICE & FIRST CHOICE PLUS (K022076) — FDA 510 (k) | Innolitics, www.accessdata.fda.gov, FIRST CHOICE & FIRST CHOICE PLUS 510 (k) K022076 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Body Clock Health Care, Ltd.

Sources (1)

  • FDA 510(k) K022076 24 fields · synced Sep 22, 2026