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FDA 510(k)

ELEVARE, PERFECTIO 4

K-Number: K172909 · 2018-06-07

ApplicantOmm Imports D/B/A Zero Gravity
Decision Date2018-06-07
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELEVARE, PERFECTIO 4 is the device name listed in this FDA 510(k) record. The listed applicant is Omm Imports D/B/A Zero Gravity. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K172909. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEVARE, PERFECTIO 4?

ELEVARE, PERFECTIO 4 is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Omm Imports D/B/A Zero Gravity. The 510(k) number is K172909.

When did ELEVARE, PERFECTIO 4 receive FDA 510(k) clearance?

ELEVARE, PERFECTIO 4 received FDA 510(k) clearance on 2018-06-07, under 510(k) number K172909.

Who is the listed applicant for ELEVARE, PERFECTIO 4?

The FDA 510(k) record lists Omm Imports D/B/A Zero Gravity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELEVARE, PERFECTIO 4?

The FDA product code for ELEVARE, PERFECTIO 4 is OHS.

Related Devices (Code: OHS)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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