FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ManaSport+
K Number: K222098
·
Decision Mar 8, 2023
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
7
Review Days
233
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ManaSport+
- K Number
- K222098
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Manamed, Inc.
- Date Received
- July 18, 2022
- Decision Date
- March 8, 2023
- Product Code
- IMI
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IMI), ordered by most recent decision date.
Ultrasound Stimulator
FDA 510(k)
FDA Class 2
·Physical Medicine
Sonopuls 190
FDA 510(k)
FDA Class 2
·Physical Medicine
ManaSport
FDA 510(k)
FDA Class 2
·Physical Medicine
Sonomed IV, Sonomed V
FDA 510(k)
FDA Class 2
·Physical Medicine
BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)
FDA 510(k)
FDA Class 2
·Physical Medicine
JAS Pulse(TM) Ultrasonic Therapy
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Manamed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231569 | ManaFlexx 2 (model: MF002-RX, MF002-OTC) | Nov 3, 2023 | Substantially Equivalent |
| K210284 | ManaSport | Apr 26, 2022 | Substantially Equivalent |
| K211253 | PlasmaWave | May 26, 2021 | Substantially Equivalent |
| K200353 | ManaFlow | Aug 6, 2020 | Substantially Equivalent |
| K200351 | PlasmaFlight | Aug 5, 2020 | Substantially Equivalent |
| K160318 | PlasmaFlow | Apr 1, 2016 | Substantially Equivalent |