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FDA 510(k)

T.E.N.S. DEVICE MODEL SPL 2000

K-Number: K872398 · 1987-07-29

ApplicantSpartan Laboratories, Inc.
Decision Date1987-07-29
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

T.E.N.S. DEVICE MODEL SPL 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-29 under 510(k) number K872398. 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 T.E.N.S. DEVICE MODEL SPL 2000?

T.E.N.S. DEVICE MODEL SPL 2000 is a medical device that received FDA 510(k) clearance on 1987-07-29. The listed applicant is Spartan Laboratories, Inc.. The 510(k) number is K872398.

When did T.E.N.S. DEVICE MODEL SPL 2000 receive FDA 510(k) clearance?

T.E.N.S. DEVICE MODEL SPL 2000 received FDA 510(k) clearance on 1987-07-29, under 510(k) number K872398.

Who is the listed applicant for T.E.N.S. DEVICE MODEL SPL 2000?

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

What is the FDA product code for T.E.N.S. DEVICE MODEL SPL 2000?

The FDA product code for T.E.N.S. DEVICE MODEL SPL 2000 is GZJ.

Related Clinical Trials

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.

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Other records listing Spartan Laboratories, 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.

K872399T.E.N.S. DEVICE MODEL SPL 2000S

Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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