FDA 510(k)

I.FLEX BY TCS

K-Number: K123396 · 2013-01-10

ApplicantThermoplastic Comfort Systems, Inc.

Decision Date2013-01-10

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

I.FLEX BY TCS is the device name listed in this FDA 510(k) record. The listed applicant is Thermoplastic Comfort Systems, Inc.. It received FDA 510(k) clearance on 2013-01-10 under 510(k) number K123396. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I.FLEX BY TCS?

I.FLEX BY TCS is a medical device that received FDA 510(k) clearance on 2013-01-10. The listed applicant is Thermoplastic Comfort Systems, Inc.. The 510(k) number is K123396.

When did I.FLEX BY TCS receive FDA 510(k) clearance?

I.FLEX BY TCS received FDA 510(k) clearance on 2013-01-10, under 510(k) number K123396.

Who is the listed applicant for I.FLEX BY TCS?

The FDA 510(k) record lists Thermoplastic Comfort Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I.FLEX BY TCS?

The FDA product code for I.FLEX BY TCS is EBI.

Other records listing Thermoplastic Comfort Systems, Inc. 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.

K053060TCS UNBREAKABLE

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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.