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FDA 510(k)

SCHULDT* PC* - DUAL CHANNEL TENS

K-Number: K880980 · 1988-04-11

ApplicantSchuldt Laboratories, Inc.
Decision Date1988-04-11
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SCHULDT* PC* - DUAL CHANNEL TENS 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 1988-04-11 under 510(k) number K880980. 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* PC* - DUAL CHANNEL TENS?

SCHULDT* PC* - DUAL CHANNEL TENS is a medical device that received FDA 510(k) clearance on 1988-04-11. The listed applicant is Schuldt Laboratories, Inc.. The 510(k) number is K880980.

When did SCHULDT* PC* - DUAL CHANNEL TENS receive FDA 510(k) clearance?

SCHULDT* PC* - DUAL CHANNEL TENS received FDA 510(k) clearance on 1988-04-11, under 510(k) number K880980.

Who is the listed applicant for SCHULDT* PC* - DUAL CHANNEL TENS?

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* PC* - DUAL CHANNEL TENS?

The FDA product code for SCHULDT* PC* - DUAL CHANNEL TENS 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 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.

K864368SCHULDT* PLUS 8 T.E.N.S. DEVICE

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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