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 a medical device manufactured by Omm Imports D/B/A Zero Gravity. It received FDA 510(k) clearance on 2018-06-07 under approval 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. It is manufactured by Omm Imports D/B/A Zero Gravity. The 510(k) number is K172909.
When was ELEVARE, PERFECTIO 4 approved by the FDA?
ELEVARE, PERFECTIO 4 received FDA 510(k) clearance on 2018-06-07, under approval number K172909.
What company makes ELEVARE, PERFECTIO 4?
ELEVARE, PERFECTIO 4 is manufactured by Omm Imports D/B/A Zero Gravity.
What is the FDA product code for ELEVARE, PERFECTIO 4?
The FDA product code for ELEVARE, PERFECTIO 4 is OHS.
Related Devices (Code: OHS)
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.