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Skylark Device Co., Ltd.

TaiwanFDA applicant, unverified

Devices
20

What Skylark Device Co., Ltd. makes

Skylark Device Co., Ltd. manufactures transcutaneous electrical nerve stimulation (TENS) units, including models like the MICRO 100–400 series and SD-605 SD II PROGRAM, as well as electrical muscular stimulators (EMS) such as the EMS300, EMS400, and SD-970EMS. Their portfolio also includes specialized TENS devices like the GB-1002 TENS with massage, the IT-727 (Dynaphor II), and the STAT-TENS, alongside conductive gels for electrode application.

All listed devices fall under FDA Class II regulation and are supported by 510(k) clearances. The company’s products are registered in the FDA’s 510(k) database, and Skylark Device Co., Ltd. is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

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  • Micro 100, 200, 300, & 400 Tens Ref K923298

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sd-605 Sd Ii Program Ref K923935

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bio Sdp (Aka Saturn Sd, Glc-Iii Sd & Stat-Sd) Ref K934051

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • It-727 (Also Known As It-610, It-600 And Dynaphor Ii Ref K946337

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sd-610M(Also Known As Standard Tens, Sd-609M, Sd-611M, Glc-I Standard) Ref K963729

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • IF400 Ref K930535

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Gb-1002 Tens With Massage Ref K964437

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EMS300, EMS400, EMS8000 Ref K912642

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sd-970EMS Electrical Muscular Stimulator Ref K964434

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Batch #6060 Conductive Gel Ref K983964

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Tx-3 Sd Ref K923934

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Stat-Tens Ref K931079

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Bio Tens 601, 606 And 608 (3000) Ref K912178

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sd-956 Ultrasound Therapy Ref K981449

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • PGS123 And Hvs-123 Ref K946299

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sd-602 Sd Mode 11, Sd-603 Sd Mod 111 Ref K925729

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • St-302 Infrarex Ref K990233

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • If-727 Interferential Stimulator Ref K974585

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Electrode Ref K912643

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sd-100 Skyear Thermometer Ref K984506

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-20 of 20

Frequently asked questions

How many devices does Skylark Device Co., Ltd. have in the registry?

The registry currently lists 20 devices for Skylark Device Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Skylark Device Co., Ltd.'s devices?

Among its 20 most recently registered devices, Skylark Device Co., Ltd. has devices listed in FDA 510(k) (20 devices).

What risk classes do Skylark Device Co., Ltd.'s devices fall under?

Among its 20 most recently registered devices, the classes recorded for Skylark Device Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Skylark Device Co., Ltd. in the registry?

The most recently registered devices listed for Skylark Device Co., Ltd. include MICRO 100, 200, 300, & 400 TENS, SD-605 SD II PROGRAM, BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD) and IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II.

Generated automatically from registry data and not verified by a human reviewer.