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FDA 510(k)

SCHULDT* PLUS 8 T.E.N.S. DEVICE

K-Number: K864368 · 1987-02-26

ApplicantSchuldt Laboratories, Inc.
Decision Date1987-02-26
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SCHULDT* PLUS 8 T.E.N.S. DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Schuldt Laboratories, Inc.. It received FDA 510(k) clearance on 1987-02-26 under 510(k) number K864368. 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 SCHULDT* PLUS 8 T.E.N.S. DEVICE?

SCHULDT* PLUS 8 T.E.N.S. DEVICE is a medical device that received FDA 510(k) clearance on 1987-02-26. The listed applicant is Schuldt Laboratories, Inc.. The 510(k) number is K864368.

When did SCHULDT* PLUS 8 T.E.N.S. DEVICE receive FDA 510(k) clearance?

SCHULDT* PLUS 8 T.E.N.S. DEVICE received FDA 510(k) clearance on 1987-02-26, under 510(k) number K864368.

Who is the listed applicant for SCHULDT* PLUS 8 T.E.N.S. DEVICE?

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

What is the FDA product code for SCHULDT* PLUS 8 T.E.N.S. DEVICE?

The FDA product code for SCHULDT* PLUS 8 T.E.N.S. DEVICE is GZJ.

Related Clinical Trials

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Other records listing Schuldt 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.

K880980SCHULDT* PC* - DUAL CHANNEL TENS

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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