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FDA 510(k)

GB-1002 TENS WITH MASSAGE

K-Number: K964437 · 1998-08-14

ApplicantSkylark Device Co., Ltd.
Decision Date1998-08-14
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GB-1002 TENS WITH MASSAGE 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 1998-08-14 under 510(k) number K964437. 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 GB-1002 TENS WITH MASSAGE?

GB-1002 TENS WITH MASSAGE is a medical device that received FDA 510(k) clearance on 1998-08-14. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K964437.

When did GB-1002 TENS WITH MASSAGE receive FDA 510(k) clearance?

GB-1002 TENS WITH MASSAGE received FDA 510(k) clearance on 1998-08-14, under 510(k) number K964437.

Who is the listed applicant for GB-1002 TENS WITH MASSAGE?

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 GB-1002 TENS WITH MASSAGE?

The FDA product code for GB-1002 TENS WITH MASSAGE is GZJ.

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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 GELK974585IF-727 INTERFERENTIAL STIMULATORK964434SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

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Related Devices (Code: GZJ)

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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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