Verimed Myo/Prems

FDA 510(k) K874212 · Verimed Holdings, Inc.

Substantially Equivalent

510(k) numberK874212

Submission

Device name
Verimed Myo/Prems
Applicant
Verimed Holdings, Inc.
Fort Lauderdale, FL, US
Received
October 16, 1987
Decision date
August 8, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPF – Stimulator, Muscle, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5850
Specialty
Physical Medicine

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More from Sunmed, LLC

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K981277PeriformHIR · Traditional 11/20/1998SE
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K930670Phyaction 787IPF · Traditional 07/02/1993SE
K922550Romas (Range of Motion Assessment System)KQX · Traditional 12/10/1992SE
K913912Verimed PerineometerHIR · Traditional 06/16/1992SE
K893220Verimed Myoexorciser VeristimIPF · Traditional 03/07/1990SE
K892649Verimed Myoexorciser III (Myo III)HCC · Traditional 12/13/1989SE
K854193Electro-Myographic PerineometerHIR · Traditional 06/09/1986SE
K852963Myo-ActuatorHCC · Traditional 01/21/1986SE

Questions and answers

When was Verimed Myo/Prems cleared by the FDA?

Verimed Myo/Prems (K874212) received a 510(k) decision of Substantially Equivalent on August 8, 1988, 297 days after the submission was received.

What is the product code of K874212?

The FDA product code is IPF – Stimulator, Muscle, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5850.