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FDA 510(k)

SMART-TENS, MODEL 456

K-Number: K961376 · 1996-09-12

ApplicantBio-Medical Research, Ltd.
Decision Date1996-09-12
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMART-TENS, MODEL 456 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Research, Ltd.. It received FDA 510(k) clearance on 1996-09-12 under 510(k) number K961376. 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 SMART-TENS, MODEL 456?

SMART-TENS, MODEL 456 is a medical device that received FDA 510(k) clearance on 1996-09-12. The listed applicant is Bio-Medical Research, Ltd.. The 510(k) number is K961376.

When did SMART-TENS, MODEL 456 receive FDA 510(k) clearance?

SMART-TENS, MODEL 456 received FDA 510(k) clearance on 1996-09-12, under 510(k) number K961376.

Who is the listed applicant for SMART-TENS, MODEL 456?

The FDA 510(k) record lists Bio-Medical Research, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMART-TENS, MODEL 456?

The FDA product code for SMART-TENS, MODEL 456 is GZJ.

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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.

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