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FDA 510(k)

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS

K-Number: K991397 · 2000-02-11

ApplicantSein Electronics Co., Ltd.
Decision Date2000-02-11
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS is the device name listed in this FDA 510(k) record. The listed applicant is Sein Electronics Co., Ltd.. It received FDA 510(k) clearance on 2000-02-11 under 510(k) number K991397. 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 TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS?

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS is a medical device that received FDA 510(k) clearance on 2000-02-11. The listed applicant is Sein Electronics Co., Ltd.. The 510(k) number is K991397.

When did TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS receive FDA 510(k) clearance?

TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS received FDA 510(k) clearance on 2000-02-11, under 510(k) number K991397.

Who is the listed applicant for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS?

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

What is the FDA product code for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS?

The FDA product code for TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS is GZJ.

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Other records listing Sein Electronics Co., Ltd. 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.

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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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