Pending FDA Registration of TRX® Suspension Trainer™
Class I - # 3027605519
Class I Product & Medical Establishment Information:
The Suspension Training® family of products is sold by TRX (JFXD TRX ACQ LLC) and these products are registered with the U.S. Food and Drug Admiration (“FDA”) as a Class I, IOD Medical Device since 2023 and should be considered pending FDA registration as TRX undertakes Class II efforts in an abundance of caution.. Public information on both the Medical Establishment Registration and the Device Listing at the FDA Can be found online 1
Establishment: JFXD TRX ACQ LLC
Registration Number: 3027605519 (Active 2024)
FEI Number: 3027605519
Owner/Operator Number: 10088404
Proprietary Name: TRX Suspension Trainer
Classification Name: Components, Exercise
Regulation Number: 890.5350 (Physical Medicine)
The Product is 510(k) Exempt
The Class I Medical Devices:
The family of TRX Suspension Trainers™ comprises a handheld and manually operated strap-based exercise invented in 2003. They have been used widely and broadly for over two decades alone or in conjunction with other devices for the treatment, rehabilitation, or injury risk reduction via live, online or one-on-one protocol with a therapist, or medical service provider. Use by these medical professionals or para-medical professionals has always been done at their sole direction and discretion. For example, the TRX Suspension Trainers™ have been wisely used by the U.S. Veterans Affairs to help military and retired military personal as part of medical-prescribed protocols of rehabilitation, injury prevention, and treatment.
Suggested Medical Use as Class I Device:
The TRX Suspension Trainer™ was first released in the market and sold to the military for the purpose of enhancing physical health, strength, fitness, and exercise. Since its release, it has been used broadly by different medical professionals as medical device and more than 75+ independent peer-reviewed articles have been published. The Class I Registration with the FDA cements the notion that these products can be used at home anchored to a wall or using the door anchor using one of the TRX®-approved anchoring methods and offers a pending registration status as it completes additional barriers. Any user and medical service provider should contact TRX® and/or follow closely all anchoring guidance and instructions and strap replacement protocols prior to use. The TRX Suspension Trainer™ can also be used in other locations such as medical facilities, care facilities, chiropractic offices, rehabilitation clinics therapeutic locations and service providers or as a portable tool for use by medical therapists and other medical-related service providers. The TRX Suspension Trainer™ is specifically adapted for use when a portion of the body is disabled, a person’s body is too weak for bodyweight exercise and requires support using the TRX Suspension Trainer™ or even when a user is bedridden, in a wheelchair, or has other mobility issue. The TRX Suspension Trainer™ can also be installed and used to help with therapeutic exercises for people with a muscle flexibility need.
While TRX is pending and registered as a Class I medical device provider, it is not a source of medical-related information, does not offer medical-qualified protocols of treatment or rehabilitation and any information given online by TRX is offered exclusively as supporting documentation for medical-approved service provider and medical-related professionals certified to offer medical services. TRX believes it is best-in-class and the only strap-based product that should be used on the market. From experience, many products are offered and may constitute a hazard including counterfeit products. TRX’s efforts to help regulate this field are designed to help experts or service providers protect clients. All medical and health-related uses should be done in conjunction, approval and at the explicit supervision by a qualified medical service provider.
Suggested Medical Use as Class I Device:
TRX believes and supporting research indicates that the TRX Suspension Trainer™ can be used for medical benefits such as the repair, stretching and mobility of muscles, restoration of motion of joints, improvement in strength and stability, and treatment for obesity. The benefits may include injury and surgery rehabilitation, the reduction of future injuries and improves aging-related biomechanics. Tangential benefits can also include mental health recovery for injured individual using the TRX Suspension Trainer™ to help with physical recovery.
Class I medical devices are devices with low or moderate risk to patient risk and safety. Class I devices are normally exempt from the MPA pathway to regulatory approval. The only limited risk of use is linked with poor or improper anchoring of the product. TRX recommends also use of the device and angling of the body over a soft surface. The TRX Suspension Trainer™ is not a Class II or Class III device and is not approved by the FDA.
A QR Code is found on each TRX Suspension Trainer™ under the stitch guard on top of the handle. Use the Code to validate the product is genuine and within the warranty period of two years.
The TRX Suspension Trainer™
May Be FSA/HSA/HRA Reimbursable
The TRX Suspension Trainer™ is a Class I FDA Registered Medical Device and when purchased primary for the purpose of use as a medical device, is reimbursable under most health plans. The TRX Suspension Trainer™ is a multi-purpose device that can be purchased and used for other purposes outside of a qualified medical disease not eligible for reimbursement.
Under IRS rules, for any claim of tax exemption under itemized deductions or as part of a medical plan, the TRX Suspension Trainer must be acquired with the PRIMARY purpose to mitigate a health condition. Such purpose can be supported either with a letter of medical necessity, as part of a medical treatment or para-medical treatment from a medical service provider or to address and treat a diagnosed condition from a doctor. If acquired by a medical service provider or a para-medical service provider for providing care for patients or customers (e.g. chiropractors), the purchase must also be primarily as a medical device for the treatment and mitigation of a health condition as provided by IRS tax codes for service providers.
Most legitimate medical expenses allow for reimbursements under the U.S. Tax Code by patients. Also, medical devices have a different standing for medical service providers and para-medical service providers at the time of tax filing. For individuals, the IRS regulations allow for the deduction of medical expenses either via itemized deductions or using a Flexible Spending Account (FSA), a Health Savings Account (HAS), a Medical Savings Account (Archer MSA and Medicare Advantage MSA), a Health Flexible Spending Arrangements (FSA), or a Health Reimbursement Arrangement (HRA) as pre-tax spending plans that allows for payment of medical devices using pre-tax revenues. (See IRS Publication No. 969 on Health Savings Accounts and Other Tax-Favored Health Plans IRS.gov/Pub969).
Common IRS-Qualified Medical expenses, described in Publication No. 502 (IRS.gov/Pub502) provides for deductions above a 7.5% of adjusted gross income (AGI). We encourage you to visit and read this publication if your medical expenses exceed this limit. For others, one of the qualified health plans, such as an FSA Health plan may be better adapted.³
Only qualified aka eligible medical expenses not covered by their health plans can be reimbursed using FSA funds and other medical plan funds. These can include medical Class I products as long as the products purchased, and expenses qualifies under IRS regulations as “medical device” as used. For a weight-loss device to qualify as a qualified medical expense, it must treat specific disease diagnosed by a physician such as obesity, diabetes, hypertension or hearth disease. The TRX Suspension Trainer™ is a Class I FDA Registered device for the treatment of obesity and diabetes but a third-party confirmation is required before the primary purpose of the product can be qualified as medical device.
The TRX Suspension Trainer™ is FDA Registered and can be used for medical benefits such as the repair, stretching and mobility of muscles, restoration of motion of joints, improvement in strength and stability, and treatment for obesity. The benefits may include injury and surgery rehabilitation, the reduction of future injuries and improves aging-related biomechanics. Tangential benefits can also include mental health recovery for injured individual using the TRX Suspension Trainer™ to help with physical recovery. Any purchase to address such uses, with supporting documentation likely qualifies as a eligible medical expenses under IRS rules and is FSA and other health plan eligible.
Gym equipment costs, like a gym membership costs to a user can only qualify as qualified medical expenses if the use is the sole purpose of (1) affecting a structure or function of the body, such as part of a prescribed plan for physical therapy to treat an injury or 2) treating a specific disease diagnosed by a physician such as obesity, hypertension or heart disease. The cost of therapy for treatment of a disease is a qualified medical expense..