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FDA 510(k)

LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE

K-Number: K880452 · 1988-03-24

ApplicantLumiscope Co., Inc.
Decision Date1988-03-24
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE is the device name listed in this FDA 510(k) record. The listed applicant is Lumiscope Co., Inc.. It received FDA 510(k) clearance on 1988-03-24 under 510(k) number K880452. 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 LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE?

LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE is a medical device that received FDA 510(k) clearance on 1988-03-24. The listed applicant is Lumiscope Co., Inc.. The 510(k) number is K880452.

When did LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE receive FDA 510(k) clearance?

LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE received FDA 510(k) clearance on 1988-03-24, under 510(k) number K880452.

Who is the listed applicant for LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE?

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

What is the FDA product code for LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE?

The FDA product code for LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE is GZJ.

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Other records listing Lumiscope Co., 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.

K032714CARDICARE MODEL MT-301F & MT-301CK954792LUMISCOPE MODEL 2018 THERMOMETERK931768INTERFERENTIAL CURRENT THERAPY UNITK925054INFRARED LAMPK924081LUMISONICK920099GYMMAN

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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