FDA.report

510(k) K210284

Device
ManaSport
Applicant
Manamed, Inc.
510(k) number
K210284
Product code
IMI
Decision
Substantially Equivalent (SESE)
Decision date
2022-04-26
Date received
2021-02-02
Regulation
890.5300
Classification name
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
Trevor Theriot
Address
5240 W. Charleston Blvd. Las Vegas NV US 89146 89146

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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