ManaSport+
FDA 510(k) K222098 · Manamed, Inc.
510(k) numberK222098
Submission
- Device name
- ManaSport+
- Applicant
- Manamed, Inc.
Las Vegas, NV, US - Received
- July 18, 2022
- Decision date
- March 8, 2023
- 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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| K240788 | Ultrasound StimulatorIMI · Traditional | Jkh Health Co., Ltd. | 06/04/2025SE |
| K230472 | Sonopuls 190IMI · Traditional | Enraf-Nonius, B.V. | 10/24/2023SE |
| 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 |
| K131309 | Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIMI · Traditional | Ibramed Equipamentos Medicos | 01/27/2014SE |
More from Ibramed Equipamentos Medicos
| 510(k) | Device | Decision |
|---|---|---|
| K260944 | ManaCold Compression SystemIRP · Traditional | 08/12/2026SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | 09/17/2025SE |
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC)NUH · Traditional | 11/03/2023SE |
| K210284 | ManaSportIMI · Traditional | 04/26/2022SE |
| K211253 | PlasmaWaveJOW · Special | 05/26/2021SE |
| K200353 | ManaFlowJOW · Traditional | 08/06/2020SE |
| K200351 | PlasmaFlightIRP · Traditional | 08/05/2020SE |
| K160318 | PlasmaFlowJOW · Traditional | 04/01/2016SE |
Questions and answers
When was ManaSport+ cleared by the FDA?
ManaSport+ (K222098) received a 510(k) decision of Substantially Equivalent on March 8, 2023, 233 days after the submission was received.
What is the product code of K222098?
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.