MC1 Plus

Q: When was MC1 Plus cleared by the FDA?

MC1 Plus (K161502) received a 510(k) decision of Substantially Equivalent on August 16, 2016, 76 days after the submission was received.

Q: What is the product code of K161502?

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.

FDA 510(k) K161502 · General Project S.R.L.

Substantially Equivalent

510(k) numberK161502

Submission

Device name: MC1 Plus
Applicant: General Project S.R.L.
Montespertoli, IT
Received: June 1, 2016
Decision date: August 16, 2016
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

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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K160075	Accent XLIMI · Traditional	Alma Lasers, Inc.	08/17/2016SE
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K131309	Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIMI · Traditional	Ibramed Equipamentos Medicos	01/27/2014SE

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Questions and answers

When was MC1 Plus cleared by the FDA?

MC1 Plus (K161502) received a 510(k) decision of Substantially Equivalent on August 16, 2016, 76 days after the submission was received.

What is the product code of K161502?

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.