FDA 510(k)

1818 TENS UNIT

K-Number: K992709 · 1999-11-09

Decision Date1999-11-09

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

1818 TENS UNIT is the device name listed in this FDA 510(k) record. The listed applicant is 138 Medical Supplies, Inc.. It received FDA 510(k) clearance on 1999-11-09 under 510(k) number K992709. 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 1818 TENS UNIT?

1818 TENS UNIT is a medical device that received FDA 510(k) clearance on 1999-11-09. The listed applicant is 138 Medical Supplies, Inc.. The 510(k) number is K992709.

When did 1818 TENS UNIT receive FDA 510(k) clearance?

1818 TENS UNIT received FDA 510(k) clearance on 1999-11-09, under 510(k) number K992709.

Who is the listed applicant for 1818 TENS UNIT?

The FDA 510(k) record lists 138 Medical Supplies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1818 TENS UNIT?

The FDA product code for 1818 TENS UNIT is GZJ.

Other records listing 138 Medical Supplies, 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.

K000741EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188

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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.