Axiom NVP8500

FDA 510(k) K051135 · Axiom Worldwide, Inc.

Substantially Equivalent

510(k) numberK051135

Submission

Device name
Axiom NVP8500
Applicant
Axiom Worldwide, Inc.
Tampa, FL, US
Received
May 3, 2005
Decision date
August 11, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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

Other 510(k)s with product code IPF

510(k)DeviceApplicantDecision
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
K060735DRX9000 True Spinal Decompression SystemITH · Traditional 05/26/2006SE
K050687Axiom EPS8000IPF · Traditional 07/28/2005SE
K010292DRX 2000ITH · Traditional 05/01/2001SE

Questions and answers

When was Axiom NVP8500 cleared by the FDA?

Axiom NVP8500 (K051135) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 100 days after the submission was received.

What is the product code of K051135?

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