Firm-A-Tron

FDA 510(k) K810634 · Biotron , Ltd.

Substantially Equivalent

510(k) numberK810634

Submission

Device name
Firm-A-Tron
Applicant
Biotron , Ltd.
Mchenry, IL, US
Received
March 10, 1981
Decision date
June 12, 1981
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

Other 510(k)s with product code IPF

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K253542Apollo Quattro (APQ-10M)IPF · Traditional Weero Co., Ltd.06/08/2026SE
K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)IPF · Traditional Mohammadali Nezakati06/02/2026SE
K260142StimelMD (SSMD) systemIPF · Special Motion Informatics ltd.05/27/2026SE
K251083Compact IIIPF · Traditional Enraf-Nonius, B.V.09/12/2025SE
K241433EVE Synergy (EVE-20M)IPF · Traditional Weero Co., Ltd.06/04/2025SE
K241488TrainFES AdvanceIPF · Traditional Trainfes02/05/2025SE
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

More from Sunmed, LLC

510(k)DeviceDecision
K910135The Universal Cement Plug(Tm)LZN · Traditional 03/05/1991SE
K843583Firm-A-Tron Mark XIPF · Traditional 11/29/1984SE
K780802Armtrol and FermtrolJJW · Traditional 06/13/1978SE
K780803Till-U-Test, Dip SlideJXA · Traditional 06/06/1978SE

Questions and answers

When was Firm-A-Tron cleared by the FDA?

Firm-A-Tron (K810634) received a 510(k) decision of Substantially Equivalent on June 12, 1981, 94 days after the submission was received.

What is the product code of K810634?

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