Decision Date2001-01-18
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
TRAK BACK II is the device name listed in this FDA 510(k) record. The listed applicant is Jomed, Inc.. It received FDA 510(k) clearance on 2001-01-18 under 510(k) number K003938. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TRAK BACK II?
TRAK BACK II is a medical device that received FDA 510(k) clearance on 2001-01-18. The listed applicant is Jomed, Inc.. The 510(k) number is K003938.
When did TRAK BACK II receive FDA 510(k) clearance?
TRAK BACK II received FDA 510(k) clearance on 2001-01-18, under 510(k) number K003938.
Who is the listed applicant for TRAK BACK II?
The FDA 510(k) record lists Jomed, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TRAK BACK II?
The FDA product code for TRAK BACK II is DQO.
Other records listing Jomed, Inc. as applicant
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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.