Massage Devices are non-invasive medical devices designed to deliver controlled mechanical or physical stimulation to the body for therapeutic purposes, including temporary relief of minor muscle aches, promotion of muscle relaxation, and improvement of local circulation. These devices operate through modalities such as vibration, rolling, kneading, compression, suction, heat, or combinations thereof.

Intended Use of Massage Items

Massage Devices are non-invasive medical devices intended for medical purposes to provide controlled mechanical or physical stimulation to body tissues for the temporary relief of minor muscle aches, pain, soreness, and discomfort; promotion of muscle relaxation; improvement of local circulation; and support of the healing process of inflamed or mildly traumatized tissues. These devices may apply stimulation through modalities such as vibration, compression, kneading, stroking, pressure, suction, thermal energy, or a combination thereof. Depending on the design, massage devices may be intended for external application or, where indicated, for internal use under medical supervision. These devices are not intended to diagnose, cure, or treat disease but are intended to provide symptomatic relief and general musculoskeletal comfort.

*510 (K) Exempt Massage items aren’t required to undergo the 510k submission process.

Bath, Hydro-Massage

Intended Use:

It is used in hydrotherapy to relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for the removal of contaminated tissue.

Device Description:

An Immersion Hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. The bathing system consists of a tub composed of fiberglass, which is covered by a panel containing all the integrated technical controls of the system. The bathing system is offered with or without a tub height positioning system, tub tit system, hydro massage and an integrated disinfection system. The bathing system is not a sterile device.

 Massager, Powered Inflatable Tube

Intended Use:

It is intended for the temporary relief of minor muscle aches and pains and for temporary increase in blood circulation to the treated areas in people who are in good health. It simulates kneading and stroking of tissues by using an inflatable garment.

Device Description:

The Powered Inflatable Tube Massager is a non-invasive, electrically powered medical device that delivers therapeutic massage to the lower extremities through controlled pneumatic compression. It uses an internal air pump to inflate and deflate integrated air chambers within a wearable sleeve, with solenoid valves regulating the compression cycles. These rhythmic, sequential, or intermittent compression patterns simulate manual kneading and stroking motions to promote muscle relaxation, enhance local circulation, and provide temporary relief from minor muscle aches and discomfort.

Massager, Therapeutic, to Internally Massage Trigger Points in the Pelvic Floor Musculature

Intended Use:

The Internal Therapeutic Massager is a prescription medical device intended to provide manual, localized pressure to myofascial trigger points in the pelvic floor musculature. The device is used to relieve pain, tenderness, and muscle tightness associated with chronic pelvic pain syndromes by enabling controlled internal massage of affected tissues. The device is inserted rectally or vaginally and provides quantitative feedback to the user regarding the applied force to the target tissue.

Device Description:

The Internal Therapeutic Massager is a hand-held, manually operated device designed for rectal or vaginal use. It consists of an elongated shaft with a contoured, hook-shaped distal end to allow targeted access to pelvic floor musculature and a proximal handle for controlled manipulation. The device incorporates a force-measuring gauge that provides real-time quantitative feedback on the pressure applied to the target tissue. The device is intended to facilitate precise manual massage of internal trigger points to reduce sensitivity, muscle tension, and localized pain.

Massager, Therapeutic, To Internally Massage Trigger Points In The Pelvic Floor Musculature, Prescription Use

Intended Use:

The Internal Therapeutic Massager is a prescription medical device intended to manually apply controlled pressure to irritable and painful trigger points within the pelvic floor musculature. The device is used to reduce internal pelvic floor trigger point sensitivity and associated discomfort in patients with pelvic floor dysfunction and chronic pelvic pain conditions.

Device Description:

The device is a hand-held, manually operated internal therapeutic massager intended for rectal or vaginal use. It consists of an extended shaft with a contoured, hook-shaped distal end, an ergonomic handle, and an integrated force-measuring gauge that provides quantitative feedback to the user regarding the applied pressure. The device includes a disposable or removable hygienic covering to facilitate safe and sanitary use. The device operates through manual manipulation and does not contain any powered components. It is Prescription device.

Massager, Vacuum, Light Induced Heating

Intended Use:

The Laser Surgical Instrument is an electrically powered medical device intended for use in general surgery, plastic surgery, and dermatology to cut, ablate, destroy, coagulate, or remove soft tissue through the controlled delivery of focused laser light energy. Depending on the configuration, the device may utilize carbon dioxide (CO₂) or argon laser energy to achieve precise tissue interaction for surgical and dermatologic procedures. The device is intended for use by trained healthcare professionals in clinical environments.

Device Description:

The device is a non-invasive, electrically powered therapeutic massager system consisting of a main console mounted on a mobile rolling stand with pivoting wheels and multiple interchangeable handpieces. The handpieces are equipped with motorized rollers that provide controlled mechanical stimulation to the skin and underlying soft tissues. Some handpieces incorporate vacuum-assisted suction and/or localized thermal or light-induced heating to enhance tissue manipulation. The system is manually guided by a trained operator and is intended for external application only.

Dermal Cooling Pack/Vacuum/Massager

Intended Use:

A contact cooling system for aesthetic use is a device that is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption of adipocyte cells intended for non-invasive aesthetic use.

Device Description:

The device is a non-invasive, electrically powered contact cooling system for aesthetic use that delivers controlled cooling to targeted body areas. It consists of a main control unit and detachable applicators incorporating a cooling pad with optional vacuum-assisted suction and/or mechanical massage. The system uses thermoelectric or equivalent cooling technology with integrated temperature sensors and feedback controls to maintain predefined treatment temperatures and ensure safe operation. The device is manually guided by a trained operator, intended for external use only, and may be used to temporarily alter the appearance of subcutaneous tissue, support body contouring, or reduce the circumference of selected body areas.

Massager, Vacuum, Radio Frequency Induced Heat

Intended Use:

An Electrosurgical Cutting and Coagulation Device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Device Description:

The device is a non-invasive, electrically powered therapeutic system that delivers controlled radiofrequency (RF) energy, mechanical massage, and optional vacuum-assisted suction to targeted body areas. It generates localized subcutaneous heating (typically 40 – 45 °C) to promote tissue relaxation, improve circulation, and enhance tissue manipulation. The system is manually guided, intended for external use only, and does not perform surgical cutting, ablation, or coagulation.

Massager, Therapeutic, Electric

Intended Use:

It is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Device Description:

The device is a non-invasive, electrically powered therapeutic massager for external use that delivers controlled mechanical stimulation through a handheld or stand-mounted applicator. It produces vibration, percussion, oscillation, or rolling motions using pneumatic, motor-driven, or piezoelectric mechanisms to stimulate the skin and underlying soft tissues. The system includes adjustable treatment settings and interchangeable applicators for different anatomical areas and is manually guided by the user.

Massager, Therapeutic, Manual

Intended Use:

The Manual Therapeutic Massager is a non-invasive medical device intended to provide mechanical stimulation to body tissues through manual operation for the temporary relief of minor muscle aches and pains, reduction of muscle tension, and promotion of muscle relaxation.

Device Description:

The device is a manually operated therapeutic massager designed for external use. It typically consists of a handle and a massage surface or rollers that allow the user to apply controlled pressure and mechanical stimulation to targeted areas. The device contains no powered components and relies entirely on manual force.

Expander, Breast, External

Intended Use:

The External Breast Expander is a non-invasive medical device intended to apply controlled external mechanical force to breast tissue for temporary expansion or reshaping for cosmetic or reconstructive purposes.

Device Description:

The device is an externally applied breast expansion system consisting of wearable cups or chambers and a mechanism that generates controlled negative pressure or mechanical tension. It may include a manual or powered pump with adjustable components to regulate the applied force. The device is intended for external use only and does not perform invasive procedures.

Cold Pack and Vibrating Massager

Intended Use:

A Therapeutic Vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.

Device Description:

The Therapeutic Vibrator is a non-invasive, externally applied device that provides localized vibration therapy, with optional heat or cold application, for temporary pain relief. It consists of a compact motor driven unit available in multiple shapes to accommodate different anatomical areas and may include interchangeable accessories such as cold packs or heat elements. The device is manually positioned by the user and intended for external use only.

Performance Testing for Massage Items

• Electrical Safety And Electromagnetic Compatibility
• Software Verification And Validation Testing
• Cybersecurity
• Thermal Mapping
• Drop Testing
• Sharp Edge Testing
• Water Temperature Control Accuracy
• Flow/Pressure Stability
• Biocompatibility Testing: In-Vitro Cytotoxicity, Test For Irritation And Skin Sensitization Test

Clinical Testing

No Guidance available for 510k submission