STIMEL-03

FDA 510(k) K130424 · Stimel, Ltd.

Substantially Equivalent

510(k) numberK130424

Submission

Device name
STIMEL-03
Applicant
Stimel, Ltd.
Monroe, CT, US
Received
February 20, 2013
Decision date
July 11, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K260142StimelMD (SSMD) systemIPF · Special Motion Informatics ltd.05/27/2026SE
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K240348Quantum Mitohormesis (QMT) (M2101)IPF · Abbreviated Quantumtx Pte. , Ltd.12/19/2024SE
K240992eMVFit (MVF-10M)IPF · Traditional Weero Co., Ltd.10/10/2024SE
K240234BTL-899MSIPF · Traditional BTL Industries, Inc.08/17/2024SE
K233098MYOTouch Muscle StimulatorIPF · Traditional Sunmed, LLC08/02/2024SE

Questions and answers

When was STIMEL-03 cleared by the FDA?

STIMEL-03 (K130424) received a 510(k) decision of Substantially Equivalent on July 11, 2013, 141 days after the submission was received.

What is the product code of K130424?

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