FDA 510(k)

INS - T.E.N.S.

K-Number: K770448 · 1977-03-15

Decision Date1977-03-15

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

INS - T.E.N.S. is the device name listed in this FDA 510(k) record. The listed applicant is Stimulation Technology, Inc.. It received FDA 510(k) clearance on 1977-03-15 under 510(k) number K770448. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INS - T.E.N.S.?

INS - T.E.N.S. is a medical device that received FDA 510(k) clearance on 1977-03-15. The listed applicant is Stimulation Technology, Inc.. The 510(k) number is K770448.

When did INS - T.E.N.S. receive FDA 510(k) clearance?

INS - T.E.N.S. received FDA 510(k) clearance on 1977-03-15, under 510(k) number K770448.

Who is the listed applicant for INS - T.E.N.S.?

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

What is the FDA product code for INS - T.E.N.S.?

The FDA product code for INS - T.E.N.S. is GXY.

Other records listing Stimulation Technology, 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.

K791048STIMTECH NEUROMUSCULAR STIMULATOR, C 600 K790345STIMTECH TENS ELECTRODE K781565ELECTRICAL NERVE STIMULATOR MODEL 6035 K772224NERVE STIMULATOR, ELEC. TRANSCUTANEOUS K770447EPC INSTICKS

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Official Source

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