Megapulse III Shortwave Diathermy

FDA 510(k) K153456 · Accelerated Care Plus

Substantially Equivalent

510(k) numberK153456

Submission

Device name
Megapulse III Shortwave Diathermy
Applicant
Accelerated Care Plus
Reno, NV, US
Received
December 1, 2015
Decision date
June 14, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5290
Specialty
Physical Medicine

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Questions and answers

When was Megapulse III Shortwave Diathermy cleared by the FDA?

Megapulse III Shortwave Diathermy (K153456) received a 510(k) decision of Substantially Equivalent on June 14, 2016, 196 days after the submission was received.

What is the product code of K153456?

The FDA product code is IMJ – Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5290.