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)

Explorer Mini

K-Number: K190682 · 2020-02-27

ApplicantPermobil AB
Decision Date2020-02-27
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Explorer Mini is the device name listed in this FDA 510(k) record. The listed applicant is Permobil AB. It received FDA 510(k) clearance on 2020-02-27 under 510(k) number K190682. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Explorer Mini?

Explorer Mini is a medical device that received FDA 510(k) clearance on 2020-02-27. The listed applicant is Permobil AB. The 510(k) number is K190682.

When did Explorer Mini receive FDA 510(k) clearance?

Explorer Mini received FDA 510(k) clearance on 2020-02-27, under 510(k) number K190682.

Who is the listed applicant for Explorer Mini?

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

What is the FDA product code for Explorer Mini?

The FDA product code for Explorer Mini is IPL.

Other records listing Permobil AB 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.

K191874F5 Corpus VS

Related Devices (Code: IPL)

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.

K243783Walking rehabilitation training electric wheelchair (ZW518)Shenzhen Zuowei Technology Co., Ltd.K202728Action Trackchair HawkAction Manufacturing, Inc.K203761ParaMotionPowerbasetec GmbHK191334Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08Matia Robotics (Us), Inc.K191874F5 Corpus VSPermobil ABK182257UPnRIDEUpnride Robotics , 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.

↑