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FDA 510(k)

STAT-TENS

K-Number: K931079 · 1994-06-09

ApplicantSkylark Device Co., Ltd.
Decision Date1994-06-09
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STAT-TENS is the device name listed in this FDA 510(k) record. The listed applicant is Skylark Device Co., Ltd.. It received FDA 510(k) clearance on 1994-06-09 under 510(k) number K931079. 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 STAT-TENS?

STAT-TENS is a medical device that received FDA 510(k) clearance on 1994-06-09. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K931079.

When did STAT-TENS receive FDA 510(k) clearance?

STAT-TENS received FDA 510(k) clearance on 1994-06-09, under 510(k) number K931079.

Who is the listed applicant for STAT-TENS?

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

What is the FDA product code for STAT-TENS?

The FDA product code for STAT-TENS is GZJ.

Other records listing Skylark Device 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.

K990233ST-302 INFRAREXK984506SD-100 SKYEAR THERMOMETERK981449SD-956 ULTRASOUND THERAPYK983964BATCH #6060 CONDUCTIVE GELK964437GB-1002 TENS WITH MASSAGEK974585IF-727 INTERFERENTIAL STIMULATOR

View all 20 devices →

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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