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FDA 510(k)

SD-956 ULTRASOUND THERAPY

K-Number: K981449 · 1998-12-11

ApplicantSkylark Device Co., Ltd.
Decision Date1998-12-11
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SD-956 ULTRASOUND THERAPY 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 1998-12-11 under 510(k) number K981449. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SD-956 ULTRASOUND THERAPY?

SD-956 ULTRASOUND THERAPY is a medical device that received FDA 510(k) clearance on 1998-12-11. The listed applicant is Skylark Device Co., Ltd.. The 510(k) number is K981449.

When did SD-956 ULTRASOUND THERAPY receive FDA 510(k) clearance?

SD-956 ULTRASOUND THERAPY received FDA 510(k) clearance on 1998-12-11, under 510(k) number K981449.

Who is the listed applicant for SD-956 ULTRASOUND THERAPY?

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-956 ULTRASOUND THERAPY?

The FDA product code for SD-956 ULTRASOUND THERAPY is IMI.

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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 THERMOMETERK983964BATCH #6060 CONDUCTIVE GELK964437GB-1002 TENS WITH MASSAGEK974585IF-727 INTERFERENTIAL STIMULATORK964434SD-970EMS ELECTRICAL MUSCULAR STIMULATOR

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Related Devices (Code: IMI)

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.

K240788Ultrasound StimulatorJkh Health Co., Ltd.K230472Sonopuls 190Enraf-Nonius, B.V.K222098ManaSport+Manamed, Inc.K210284ManaSportManamed, Inc.K202788Sonomed IV, Sonomed VCarci Industria E Comercio DE Aparelhos Cirurgicos E OrtoK160378BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)Brh Medical , Ltd.

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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