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FDA 510(k)

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

K-Number: K964434 · 1997-10-09

ApplicantSkylark Device Co., Ltd.
Decision Date1997-10-09
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR 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 1997-10-09 under 510(k) number K964434. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SD-970EMS ELECTRICAL MUSCULAR STIMULATOR?

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR is a medical device that received FDA 510(k) clearance on 1997-10-09. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K964434.

When did SD-970EMS ELECTRICAL MUSCULAR STIMULATOR receive FDA 510(k) clearance?

SD-970EMS ELECTRICAL MUSCULAR STIMULATOR received FDA 510(k) clearance on 1997-10-09, under 510(k) number K964434.

Who is the listed applicant for SD-970EMS ELECTRICAL MUSCULAR STIMULATOR?

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-970EMS ELECTRICAL MUSCULAR STIMULATOR?

The FDA product code for SD-970EMS ELECTRICAL MUSCULAR STIMULATOR is IPF.

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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 GELK964437GB-1002 TENS WITH MASSAGEK974585IF-727 INTERFERENTIAL STIMULATOR

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Related Devices (Code: IPF)

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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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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