SD-956 Ultrasound Therapy
FDA 510(k) K981449 · Skylark Device Co., Ltd.
510(k) numberK981449
Submission
- Device name
- SD-956 Ultrasound Therapy
- Applicant
- Skylark Device Co., Ltd.
Taipei, TW - Received
- April 22, 1998
- Decision date
- December 11, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5300
- Specialty
- Physical Medicine
Other 510(k)s with product code IMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240788 | Ultrasound StimulatorIMI · Traditional | Jkh Health Co., Ltd. | 06/04/2025SE |
| K230472 | Sonopuls 190IMI · Traditional | Enraf-Nonius, B.V. | 10/24/2023SE |
| K222098 | ManaSport+IMI · Traditional | Manamed, Inc. | 03/08/2023SE |
| K210284 | ManaSportIMI · Traditional | Manamed, Inc. | 04/26/2022SE |
| K202788 | Sonomed IV, Sonomed VIMI · Traditional | Carci Industria E Comercio DE Aparelhos… | 12/23/2021SE |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)IMI · Traditional | Brh Medical , Ltd. | 08/25/2017SE |
| K161628 | JAS Pulse(TM) Ultrasonic TherapyIMI · Abbreviated | Bonutti Research, Inc. | 11/10/2016SE |
| K160075 | Accent XLIMI · Traditional | Alma Lasers, Inc. | 08/17/2016SE |
| K161502 | MC1 PlusIMI · Special | General Project S.R.L. | 08/16/2016SE |
| K142976 | UltraTENSIMI · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 08/26/2015SE |
More from Shenzhen Dongdixin Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K990233 | ST-302 InfrarexILY · Traditional | 10/27/1999SE |
| K984506 | SD-100 Skyear ThermometerFLL · Traditional | 07/29/1999SE |
| 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 |
| K964434 | SD-970EMS Electrical Muscular StimulatorIPF · Traditional | 10/09/1997SE |
| 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-956 Ultrasound Therapy cleared by the FDA?
SD-956 Ultrasound Therapy (K981449) received a 510(k) decision of Substantially Equivalent on December 11, 1998, 233 days after the submission was received.
What is the product code of K981449?
The FDA product code is IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5300.