SW Ultrasound, Models 331, 311, 333
FDA 510(k) K991613 · Starbene
510(k) numberK991613
Submission
- Device name
- SW Ultrasound, Models 331, 311, 333
- Applicant
- Starbene
Cordoba, Pvcia. Cordoba, AR - Received
- May 10, 1999
- Decision date
- December 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
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| 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 |
|---|---|---|
| K992099 | Bio SPA IntelligentIPF · Traditional | 01/18/2002SE |
Questions and answers
When was SW Ultrasound, Models 331, 311, 333 cleared by the FDA?
SW Ultrasound, Models 331, 311, 333 (K991613) received a 510(k) decision of Substantially Equivalent on December 8, 2000, 578 days after the submission was received.
What is the product code of K991613?
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.