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)

Invacare AVIVA Storm RX Power Chair

K-Number: K202379 · 2021-03-19

Decision Date2021-03-19
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Invacare AVIVA Storm RX Power Chair is the device name listed in this FDA 510(k) record. The listed applicant is Invacare Corporation. It received FDA 510(k) clearance on 2021-03-19 under 510(k) number K202379. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Invacare AVIVA Storm RX Power Chair?

Invacare AVIVA Storm RX Power Chair is a medical device that received FDA 510(k) clearance on 2021-03-19. The listed applicant is Invacare Corporation. The 510(k) number is K202379.

When did Invacare AVIVA Storm RX Power Chair receive FDA 510(k) clearance?

Invacare AVIVA Storm RX Power Chair received FDA 510(k) clearance on 2021-03-19, under 510(k) number K202379.

Who is the listed applicant for Invacare AVIVA Storm RX Power Chair?

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

What is the FDA product code for Invacare AVIVA Storm RX Power Chair?

The FDA product code for Invacare AVIVA Storm RX Power Chair is ITI.

Other records listing Invacare Corporation 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.

View all 14 devices →

Related Devices (Code: ITI)

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.

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.