SD-970EMS Electrical Muscular Stimulator
FDA 510(k) K964434 · Skylark Device Co., Ltd.
510(k) numberK964434
Submission
- Device name
- SD-970EMS Electrical Muscular Stimulator
- Applicant
- Skylark Device Co., Ltd.
Taipei, TW - Received
- November 5, 1996
- Decision date
- October 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IPF – Stimulator, Muscle, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5850
- Specialty
- Physical Medicine
Other 510(k)s with product code IPF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253542 | Apollo Quattro (APQ-10M)IPF · Traditional | Weero Co., Ltd. | 06/08/2026SE |
| K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional | Mohammadali Nezakati | 06/02/2026SE |
| K260142 | StimelMD (SSMD) systemIPF · Special | Motion Informatics ltd. | 05/27/2026SE |
| K251083 | Compact IIIPF · Traditional | Enraf-Nonius, B.V. | 09/12/2025SE |
| K241433 | EVE Synergy (EVE-20M)IPF · Traditional | Weero Co., Ltd. | 06/04/2025SE |
| K241488 | TrainFES AdvanceIPF · Traditional | Trainfes | 02/05/2025SE |
| K240348 | Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated | Quantumtx Pte. , Ltd. | 12/19/2024SE |
| K240992 | eMVFit (MVF-10M)IPF · Traditional | Weero Co., Ltd. | 10/10/2024SE |
| K240234 | BTL-899MSIPF · Traditional | BTL Industries, Inc. | 08/17/2024SE |
| K233098 | MYOTouch Muscle StimulatorIPF · Traditional | Sunmed, LLC | 08/02/2024SE |
More from Sunmed, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K990233 | ST-302 InfrarexILY · Traditional | 10/27/1999SE |
| K984506 | SD-100 Skyear ThermometerFLL · Traditional | 07/29/1999SE |
| K981449 | SD-956 Ultrasound TherapyIMI · Traditional | 12/11/1998SE |
| K983964 | Batch #6060 Conductive GelGYB · Traditional | 12/09/1998SE |
| K964437 | GB-1002 TENS with MassageGZJ · Traditional | 08/14/1998SE |
| K974585 | IF-727 Interferential StimulatorLIH · Traditional | 03/06/1998SE |
| K963729 | SD-610M(ALSO Known AS Standard TENS, SD-609M,SD-611M, Glc-I Standard)GZJ · Traditional | 02/13/1997SE |
| K946337 | IT-727 (Also Known AS IT-610, IT-600 and Dynaphor IIEGJ · Traditional | 12/20/1995SE |
| K946299 | PGS123 and HVS-123GZJ · Traditional | 06/26/1995SE |
| K934051 | Bio SDP (Aka Saturn SD, Glc-Iii SD & Stat-Sd)GZJ · Traditional | 07/11/1994SE |
Questions and answers
When was SD-970EMS Electrical Muscular Stimulator cleared by the FDA?
SD-970EMS Electrical Muscular Stimulator (K964434) received a 510(k) decision of Substantially Equivalent on October 9, 1997, 338 days after the submission was received.
What is the product code of K964434?
The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.