Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SD-602 SD MODE 11, SD-603 SD MOD 111

K-Number: K925729 · 1993-01-22

ApplicantSkylark Device Co., Ltd.
Decision Date1993-01-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SD-602 SD MODE 11, SD-603 SD MOD 111 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 1993-01-22 under 510(k) number K925729. 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 SD-602 SD MODE 11, SD-603 SD MOD 111?

SD-602 SD MODE 11, SD-603 SD MOD 111 is a medical device that received FDA 510(k) clearance on 1993-01-22. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K925729.

When did SD-602 SD MODE 11, SD-603 SD MOD 111 receive FDA 510(k) clearance?

SD-602 SD MODE 11, SD-603 SD MOD 111 received FDA 510(k) clearance on 1993-01-22, under 510(k) number K925729.

Who is the listed applicant for SD-602 SD MODE 11, SD-603 SD MOD 111?

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 SD-602 SD MODE 11, SD-603 SD MOD 111?

The FDA product code for SD-602 SD MODE 11, SD-603 SD MOD 111 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.

↑