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FDA 510(k)

EXTRA TENS (RI-2500) NEO TENS (RI-2000E)

K-Number: K963507 · 1997-03-19

ApplicantComtek Intl., Corp.
Decision Date1997-03-19
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EXTRA TENS (RI-2500) NEO TENS (RI-2000E) is the device name listed in this FDA 510(k) record. The listed applicant is Comtek Intl., Corp.. It received FDA 510(k) clearance on 1997-03-19 under 510(k) number K963507. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTRA TENS (RI-2500) NEO TENS (RI-2000E)?

EXTRA TENS (RI-2500) NEO TENS (RI-2000E) is a medical device that received FDA 510(k) clearance on 1997-03-19. The listed applicant is Comtek Intl., Corp.. The 510(k) number is K963507.

When did EXTRA TENS (RI-2500) NEO TENS (RI-2000E) receive FDA 510(k) clearance?

EXTRA TENS (RI-2500) NEO TENS (RI-2000E) received FDA 510(k) clearance on 1997-03-19, under 510(k) number K963507.

Who is the listed applicant for EXTRA TENS (RI-2500) NEO TENS (RI-2000E)?

The FDA 510(k) record lists Comtek Intl., Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTRA TENS (RI-2500) NEO TENS (RI-2000E)?

The FDA product code for EXTRA TENS (RI-2500) NEO TENS (RI-2000E) is GZJ.

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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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