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.

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.

AI/ML Overview

The provided text describes the submission of the Fist Assist Devices Model FA-1 for FDA 510(k) clearance, asserting its substantial equivalence to predicate devices. However, the document does not contain information about a study proving the device meets specific acceptance criteria related to its efficacy in the stated indications for use (temporary relief of minor muscle aches and temporary increase in circulation).

The "acceptance criteria" discussed in the document primarily relate to non-clinical testing for safety and performance of the device's physical and electrical aspects, rather than clinical efficacy. Therefore, I cannot extract information about a study proving the device meets acceptance criteria for its intended medical benefits.

Here's what can be extracted regarding the device's non-clinical testing and performance:

Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):

The document details various non-clinical tests performed to demonstrate the device's safety and fundamental operational characteristics, comparing them to established standards.

Acceptance Criteria (Non-Clinical/Engineering)	Reported Device Performance and Compliance
Transportation Testing: Device packaging must meet standards for parcel delivery.	Tested to ISTA 3A-2018, General Simulation Performance Test Procedure for Parcel Delivery System (70kg or less). Results: All units tested met the requirements of the standard.
Biocompatibility: Materials should not cause adverse biological reactions.	"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." (Note: This is a disclosure rather than a demonstration of meeting acceptance criteria, indicating the device is intended for use over clothing to mitigate this concern).
Software Validation: Software must be validated to perform as intended.	Performed using "General Principle of Software Validations: Final Guidance for Industry and FDA Staff, dated January 11, 2002". Results: All tested variables were found to meet acceptance criteria established.
Electrical Testing: Electrical safety must meet relevant standards.	Performed using AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012. Results: The Device met all test requirements for electrical safety.
EMC Evaluation: Electromagnetic compatibility must meet standards.	Performed using IEC 60601-1-2:2014. Results: The Device met all test requirements for EMC.
Bench Testing (Mechanical Functionality): Key process parameters must function as intended.	Mechanical testing performed to confirm functionality of key process parameters. Results: All parameters tested were found to meet acceptance criteria established.
Device Pressure Range: Device operates within specified pressure limits.	Reported Performance: 10-60 mmHg. (This is a design specification, not a test result proving it always stays within this range over time or under various conditions, but it's part of the technical characterization).
Max. Inflation Pressure: Device does not exceed maximum inflation pressure.	Reported Performance: 60 mmHg, preprogrammed. (Similar to above, a design specification).
Deflation Hold Time: Device maintains specified deflation duration.	Reported Performance: 55 seconds. (Similar to above, a design specification).
Pre-Programmed Treatment Time: Device operates for specified duration and allows user control.	Reported Performance: 60-minute preprogrammed treatment. Cycle can be stopped by user. Device turns off automatically after 1 hour of continuous use. (Similar to above, a design specification and operational feature).

Information Not Available in the Provided Text:

The provided document is a 510(k) clearance letter and summary, which typically focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance data. It does not contain the following information that would be expected for a study proving clinical efficacy or diagnostic performance of an AI/ML device:

Study Proving Efficacy: No study proving the device meets acceptance criteria for its medical indications (temporary relief of muscle aches, increase in circulation) is described. The 510(k) process for this type of device often relies on comparison to known safe and effective predicate devices rather than new clinical efficacy trials.
Sample size for the test set and data provenance: N/A (no clinical efficacy test set described)
Number of experts used to establish ground truth: N/A
Qualifications of experts: N/A
Adjudication method for the test set: N/A
MRMC comparative effectiveness study: N/A
Standalone (algorithm only) performance: N/A (This is a physical device, not an algorithm-only product in the AI sense)
Type of ground truth used: N/A
Sample size for the training set: N/A
How the ground truth for the training set was established: N/A

In summary, the document confirms that the device has undergone various non-clinical engineering and safety tests and met their respective acceptance criteria. However, it does not describe a clinical study for the device's indications for use. For 510(k) clearance of this type of device (a pneumatic massager), a rigorous clinical trial demonstrating efficacy against specific endpoints with predefined acceptance criteria is often not required if substantial equivalence to a legally marketed predicate device can be demonstrated through technological comparison and non-clinical performance data.

Summary

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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

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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

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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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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, MBACEO and FounderFist Assist Devices, LLCEmail: 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)2. Fig LLC, PowerPlay PPRT-01 (K122154)3. ManaMed Inc., PlasmaFlight (K200351)

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:

1. the control module that contains the electronics with miniature pump and
1. 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.

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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.

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Fist Assist Devices, LLC Model FA-1

	Subject Device:Fist AssistDevices, LLCModel FA-1	Primary PredicateDevice:NormaTec Industries, LPPulse 2.0 and Pulse Pro2.0	Predicate Device:Fig, LLCPowerPlay PPRT-01	Predicate DeviceManaMed, Inc.PlasmaFlight
Manufacturer	Fist AssistDevices, LLC	NormaTec Industries, LP	Fig, LLC	ManaMed, Inc
510k Number	K210281	K183169	K122154	K200351
Indicationsfor Use	The Fist Assist,Model FA-1 is anarm air pressuremassager intendedto temporarilyrelieve minormuscle achesand/or pains, andto temporarilyincreasecirculation to thetreated areas.	The NormaTec Pulse andPulse Pro are air pressuremassagers intended totemporarily relieve minormuscle aches and/or pains,and to temporarily increasecirculation to the treatedareas.	The PowerPlay model PPRT-01 is intended to be an over-the-counter portable inflatabletube massage system whichsimulates kneading andstroking of tissue with thehands and by use of inflatablepressure wraps. This devicecan be used to: temporarilyincrease blood circulation inthe treated areas; andtemporary relief of minormuscle aches and pains	The PlasmaFlight is intendedto be an over-the-counterportable inflatable tubemassage system whichsimulates kneading andstroking of tissue with thehands and by use of inflatablepressure wraps. This devicecan be used to: temporarilyincrease blood circulation inthe treated areas; andtemporary relief of minormuscle aches and pains.
Technology	A single bladderwrap actuated byan electronicallycontrolled smallinternal air pumpand valve system.	Compressor and valvesystem that sequentiallyinflates cells of appliance.Bluetooth communicationability.	Single bladder compressionwraps actuated by andelectronically controlled airpump unit and solenoid valves	Airbladder encased in acovering controlled by amicropump controlled bymicroprocessor
	Subject Device:Fist AssistDevices, LLCModel FA-1	Primary PredicateDevice:NormaTec Industries, LPPulse 2.0 and Pulse Pro2.0	Predicate Device:Fig, LLCPowerPlay PPRT-01	Predicate DeviceManaMed, Inc.PlasmaFlight
CompliancewithEMC/IECVoluntarystandards?	Yes, ES 60601-1,IEC 60601-1-2,IEC 60601-1-11	Yes, ES 60601-1,IEC 60601-1-2, IEC60601-1-11	Information Not Available	Compliant to VoluntaryStandards
DevicePressureRange	10-60mmHg	0-110 mmHg	30-70 mmHg	0-55 mmHg
Weight	0.35 pounds	3.6 pounds	1.1 pounds	.51 pounds
HousingMaterials	Molded ABSenclosure (94VB)	Molded ABS enclosure(94V0)	Plastic Housing	Plastic Case
SterilizationMethod	Non-Sterile	Non-Sterile	Non-Sterile	Non-Sterile
Max.InflationPressure	60 mmHg,preprogrammed	110mmHg, set by user	70mmHg, set by user	55 mmHg
DeflationHold Time	55 seconds	Default 30 sec, but can bemanually adjusted between15 to 90 sec.	Approximately 30 seconds foreach port used,preprogrammed	Information Not Available
PrescriptionDevice	No (OTC)	No (OTC)	No (OTC)	No (OTC)
	Subject Device:Fist AssistDevices, LLCModel FA-1	Primary Predicate Device:NormaTec Industries, LPPulse 2.0 and Pulse Pro 2.0	Predicate Device:Fig, LLCPowerPlay PPRT-01	Predicate DeviceManaMed, Inc.PlasmaFlight
Pre-ProgrammedTreatmenttime	60-minutepreprogrammedtreatment. Cyclecan be stopped byuser.	10 minutes to 2h55 minutetreatment time set by user.Cycle can be stopped byuser.	20 minutes preprogrammedper port, up to 60-minute totaltreatment if all 3 ports areused. Cycle can be stopped byuser.	60-minute preprogrammedtreatment.

Table 5-1 Comparison Summary of the Model FA-1 to Predicates

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Fist Assist Devices, LLC Model FA-1

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Fist Assist Devices, LLC Model FA-1

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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.

Regulation Number and Section

§ 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).