(136 days)
Not Found
No
The device description outlines a simple, fixed-cycle pneumatic compression device with no mention of adaptive behavior, learning, or data processing beyond basic timing and pressure control. The performance studies focus on standard electrical, mechanical, and software validation, not AI/ML model performance.
Yes
The device is described as an arm massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas, which are therapeutic claims. Furthermore, it falls under the category of medical electrical equipment based on the electrical testing performed.
No
The device is described as an "arm massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas." Its function is therapeutic, providing pneumatic compression, not to diagnose a condition or disease.
No
The device description clearly states it is a wearable, non-sterile, battery operated, intermittent pneumatic compression device composed of a control module with electronics and a pump, and a wrap with an air bladder. This indicates significant hardware components beyond just software.
Based on the provided information, the Fist Assist Model FA-1 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas." This is a therapeutic or physical therapy type of use, not a diagnostic one.
- Device Description: The device is an "intermittent pneumatic compression device for use on the arm over clothing." It works by applying pressure to the arm. This mechanism is physical and external, not involving the analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. The Fist Assist Model FA-1 does not fit this description.
N/A
Intended Use / Indications for Use
The Fist Assist Model FA-1 is an arm massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.
Product codes
IRP
Device Description
The Fist Assist Model FA-1 is a wearable, non-sterile, battery operated, intermittent pneumatic compression device for use on the arm over clothing. It is composed of two major components that are permanently attached to one another:
-
- the control module that contains the electronics with miniature pump and
-
- the wrap made of elastic cloth that holds the control module and internal air bladder and uses hook tape for attachment to any part of the wrap exterior.
The control module and wrap are integral and permanently attached. It is powered by (2) AA batteries. The Fist Assist Model FA-1 has a single operation mode. When powered on by depressing the single push button switch, it goes through pressure cycles wherein the air bladder inflates to 60 mmHg and is held at that pressure for 20 seconds; the air bladder is then deflated and a minimal pressure of 10 mmHg (or less) and is held for 55 seconds until the next inflation to 60 mmHg begins again. The cycle repeats continuously until the power is turned off using the single push button switch. The device will turn off automatically after 1 hour of continuous use. When wearing this device, the device should only be used over full clothing and never on direct skin.
- the wrap made of elastic cloth that holds the control module and internal air bladder and uses hook tape for attachment to any part of the wrap exterior.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing of the Model FA-1 was performed following applicable standards.
TRANSPORTATION TESTING: Packaging testing of the Model FA-1 was performed to ISTA 3A-2018, General Simulation Performance Test Procedure for Parcel Delivery System 70kg (or 150lbs.) or less using the small packaging process sequence of testing. The results of test concluded that all units tested met the requirements of standard.
BIOCOMPATIBILITY: The biocompatibility of the materials has not been verified by the FDA and contact of the cuffs/accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity.
SOFTWARE VALIDATION: Software validation was performed using the "General Principle of Software Validations: Final Guidance for Industry and FDA Staff, dated January 11, 2002". All tested variables were found to meet acceptance criteria established.
ELECTRICAL TESTING: Electrical Testing was performed using the test standards AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. Testing concluded that the Device met all test requirements for the electrical safety.
EMC EVALUATION: Electromagnetic Compatibility (EMC) testing of the Device was performed using the test standard IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. Testing concluded that the Device met all test requirements for EMC.
BENCH TESTING: Mechanical testing was performed to confirm the functionality of key process parameters were performed. All parameters tested were found to meet acceptance criteria established.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 17, 2021
Fist Assist Devices, LLC Tej Singh CEO. Founder 25599 Fernhill Road Los Altos, California 94024
Re: K210281
Trade/Device Name: Fist Assist Devices Model FA-1 Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: March 19, 2021 Received: March 22, 2021
Dear Tej Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210281
Device Name Fist Assist Devices Model FA-1
Indications for Use (Describe)
The Fist Assist Model FA-1 is an arm massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
[as required by 21 CFR 807.92(c)]
Fist Assist Devices, Model FA-1
510(k) K210281
| DATE PREPARED: | May 25, 2021 |
|---|---|
| APPLICANT | Fist Assist Devices, LLC. |
| 25599 Fernhill Dr. | |
| Los Altos Hills, CA 94024 | |
| CONTACT | Tej Singh, MD, MBA |
| CEO and Founder | |
| Fist Assist Devices, LLC | |
| Email: fistassistdevices@gmail.com | |
| TRADE NAME: | Fist Assist Devices Model FA-1 |
| DEVICE CLASSIFICATION: | Class II per 21 CFR 890.5650 |
| CLASSIFICATION NAME: | Powered Inflatable Tube Massager |
| PRODUCT CODE | IRP |
| PREDICATE DEVICES: | 1. NormaTec Pulse 2.0 and Pulse Pro 2.0 (K183169) |
INDICATION FOR USE:
The Fist Assist Model FA-1 is an arm air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
DEVICE DESCRIPTION:
The Fist Assist Model FA-1 is a wearable, non-sterile, battery operated, intermittent pneumatic compression device for use on the arm over clothing. It is composed of two major components that are permanently attached to one another:
-
- the control module that contains the electronics with miniature pump and
-
- the wrap made of elastic cloth that holds the control module and internal air bladder and uses hook tape for attachment to any part of the wrap exterior.
The control module and wrap are integral and permanently attached. It is powered by (2) AA batteries.
4
Fist Assist Devices, LLC Model FA-1
The Fist Assist Model FA-1 has a single operation mode. When powered on by depressing the single push button switch, it goes through pressure cycles wherein the air bladder inflates to 60 mmHg and is held at that pressure for 20 seconds; the air bladder is then deflated and a minimal pressure of 10 mmHg (or less) and is held for 55 seconds until the next inflation to 60 mmHg begins again. The cycle repeats continuously until the power is turned off using the single push button switch. The device will turn off automatically after 1 hour of continuous use. When wearing this device, the device should only be used over full clothing and never on direct skin.
COMPARISON WITH PREDICATE DEVICE:
The indications for use of the Model FA-1 and its primary predicate device is identical. Additionally, there are specific design features of the Model FA-1 device that are similar to the predicate devices. Table 5-1 below provides a summary of the comparison of the Model FA-1 to its predicates. Further information on predicate comparison is located in Section 12, Substantial Equivalence Discussion.
5
Fist Assist Devices, LLC Model FA-1
| | Subject Device:
Fist Assist
Devices, LLC
Model FA-1 | Primary Predicate
Device:
NormaTec Industries, LP
Pulse 2.0 and Pulse Pro
2.0 | Predicate Device:
Fig, LLC
PowerPlay PPRT-01 | Predicate Device
ManaMed, Inc.
PlasmaFlight |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Fist Assist
Devices, LLC | NormaTec Industries, LP | Fig, LLC | ManaMed, Inc |
| 510k Number | K210281 | K183169 | K122154 | K200351 |
| Indications
for Use | The Fist Assist,
Model FA-1 is an
arm air pressure
massager intended
to temporarily
relieve minor
muscle aches
and/or pains, and
to temporarily
increase
circulation to the
treated areas. | The NormaTec Pulse and
Pulse Pro are air pressure
massagers intended to
temporarily relieve minor
muscle aches and/or pains,
and to temporarily increase
circulation to the treated
areas. | The PowerPlay model PPRT-
01 is intended to be an over-
the-counter portable inflatable
tube massage system which
simulates kneading and
stroking of tissue with the
hands and by use of inflatable
pressure wraps. This device
can be used to: temporarily
increase blood circulation in
the treated areas; and
temporary relief of minor
muscle aches and pains | The PlasmaFlight is intended
to be an over-the-counter
portable inflatable tube
massage system which
simulates kneading and
stroking of tissue with the
hands and by use of inflatable
pressure wraps. This device
can be used to: temporarily
increase blood circulation in
the treated areas; and
temporary relief of minor
muscle aches and pains. |
| Technology | A single bladder
wrap actuated by
an electronically
controlled small
internal air pump
and valve system. | Compressor and valve
system that sequentially
inflates cells of appliance.
Bluetooth communication
ability. | Single bladder compression
wraps actuated by and
electronically controlled air
pump unit and solenoid valves | Airbladder encased in a
covering controlled by a
micropump controlled by
microprocessor |
| | Subject Device:
Fist Assist
Devices, LLC
Model FA-1 | Primary Predicate
Device:
NormaTec Industries, LP
Pulse 2.0 and Pulse Pro
2.0 | Predicate Device:
Fig, LLC
PowerPlay PPRT-01 | Predicate Device
ManaMed, Inc.
PlasmaFlight |
| Compliance
with
EMC/IEC
Voluntary
standards? | Yes, ES 60601-1,
IEC 60601-1-2,
IEC 60601-1-11 | Yes, ES 60601-1,
IEC 60601-1-2, IEC
60601-1-11 | Information Not Available | Compliant to Voluntary
Standards |
| Device
Pressure
Range | 10-60mmHg | 0-110 mmHg | 30-70 mmHg | 0-55 mmHg |
| Weight | 0.35 pounds | 3.6 pounds | 1.1 pounds | .51 pounds |
| Housing
Materials | Molded ABS
enclosure (94VB) | Molded ABS enclosure
(94V0) | Plastic Housing | Plastic Case |
| Sterilization
Method | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile |
| Max.
Inflation
Pressure | 60 mmHg,
preprogrammed | 110mmHg, set by user | 70mmHg, set by user | 55 mmHg |
| Deflation
Hold Time | 55 seconds | Default 30 sec, but can be
manually adjusted between
15 to 90 sec. | Approximately 30 seconds for
each port used,
preprogrammed | Information Not Available |
| Prescription
Device | No (OTC) | No (OTC) | No (OTC) | No (OTC) |
| | Subject Device:
Fist Assist
Devices, LLC
Model FA-1 | Primary Predicate Device:
NormaTec Industries, LP
Pulse 2.0 and Pulse Pro 2.0 | Predicate Device:
Fig, LLC
PowerPlay PPRT-01 | Predicate Device
ManaMed, Inc.
PlasmaFlight |
| Pre-
Programmed
Treatment
time | 60-minute
preprogrammed
treatment. Cycle
can be stopped by
user. | 10 minutes to 2h55 minute
treatment time set by user.
Cycle can be stopped by
user. | 20 minutes preprogrammed
per port, up to 60-minute total
treatment if all 3 ports are
used. Cycle can be stopped by
user. | 60-minute preprogrammed
treatment. |
Table 5-1 Comparison Summary of the Model FA-1 to Predicates
6
Fist Assist Devices, LLC Model FA-1
7
Fist Assist Devices, LLC Model FA-1
8
Fist Assist Devices, LLC Model FA-1
NON-CLINICAL TESTING / PERFORMANCE DATA:
Non-clinical testing of the Model FA-1 was performed following applicable standards.
TRANSPORTATION TESTING
Packaging testing of the Model FA-1 was performed to ISTA 3A-2018, General Simulation Performance Test Procedure for Parcel Delivery System 70kg (or 150lbs.) or less using the small packaging process sequence of testing. The results of test concluded that all units tested met the requirements of standard.
BIOCOMPATIBILITY
The biocompatibility of the materials has not been verified by the FDA and contact of the cuffs/accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity.
SOFTWARE VALIDATION
Software validation was performed using the "General Principle of Software Validations: Final Guidance for Industry and FDA Staff, dated January 11, 2002". All tested variables were found to meet acceptance criteria established.
ELECTRICAL TESTING
Electrical Testing was performed using the test standards AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance. Testing concluded that the Device met all test requirements for the electrical safety.
EMC EVALUATION
Electromagnetic Compatibility (EMC) testing of the Device was performed using the test standard IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests. Testing concluded that the Device met all test requirements for EMC.
BENCH TESTING
Mechanical testing was performed to confirm the functionality of key process parameters were performed. All parameters tested were found to meet acceptance criteria established.
CONCLUSION:
The Model FA-1 is indicated for the identical intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended. Therefore, the Model FA-1 is substantially equivalent to the predicate device.