accufit

K233926 · Mettler Electronics Corporation · IPF · Mar 21, 2024 · Physical Medicine

Device Facts

• Record ID: K233926
• Device Name: accufit
• Applicant: Mettler Electronics Corporation
• Product Code: IPF · Physical Medicine
• Decision Date: Mar 21, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The accufit is indicated for use for Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increase local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen, and Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

Device Story

Accufit is a powered muscle stimulator console; provides direct electrical stimulation to muscles via IntelliSTIM electrodes; produces muscle contractions for conditioning and therapeutic purposes. Device features Touch LCD/GUI; offers two waveforms (Biphasic, Interferential 4P) and four protocols (twist, hold, grip, tap) plus an automated 'IntelliCycle' program. Used in clinical settings by healthcare providers; console includes emergency stop and key switch. Output intensity is adjustable (0-100 mA). Device supplements existing therapies; does not replace traditional treatment. Benefits include improved muscle tone, firmness, and strength; clinical study demonstrated increased arm strength via dynamometer measurements.

Clinical Evidence

Prospective clinical study; 45 subjects; assessed effect of bioelectric muscle activation (BMA) on arm strength and appearance. Strength measured via dynamometer at baseline, final treatment, and 30/90-day follow-ups. Results showed improved muscle strength from initial to final treatment; no significant adverse events reported.

Technological Characteristics

Powered muscle stimulator; ABS plastic housing; 2 output channels; 100-240VAC power. Waveforms: Biphasic and Interferential (4P). Safety: Type BF classification, automatic over-current/no-load trip, patient interrupt switch. Standards: IEC 60601-1, 60601-1-2, 60601-2-10, ISO 14971, UL 60601, CSA C22.2 No 606.1. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation).

Indications for Use

Indicated for patients requiring muscle stimulation for relaxation of spasms, prevention of disuse atrophy, increased local blood circulation, muscle re-education, range of motion maintenance, post-surgical calf stimulation to prevent venous thrombosis, and strengthening/toning of abdominal, arm, thigh, and buttock muscles.

Regulatory Classification

Identification

A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.

Predicate Devices

• Mettler Electronics Corporation accufit (K223802)

Reference Devices

• Johari Digital Healthcare Limited Torc Body (K192039)
• Sport-Elec Body Control System 4M (K092476)

Submission Summary (Full Text)

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March 21, 2024

Mettler Electronics Corporation Kevin O'Connell VP Global Regulatory Affairs Lutronic Corporation Lutronic Center 219, Sowon-Ro Deogyang-Gu, Goyang-Si 410220 South Korea

Re: K233926

Trade/Device Name: accufit Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, NGX Dated: March 7, 2024 Received: March 7, 2024

## Dear Kevin O'Connell:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation

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Enclosure

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## Indications for Use

510(k) Number (if known) K233926

Device Name accufit

Indications for Use (Describe)

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
- Improvement of muscle tone and firmness, for strengthening muscles in arms, thighs and buttocks areas.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) SUMMARY

## K233926

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| 807.92(a)(1) - Submitter Information | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Mettler Electronics Corporation |
| Address | 1333 South Claudina Street<br>Anaheim, CA USA 92805 |
| Phone number | 978-888-1426 |
| Fax number | N/A |
| Name of contact person | An Le<br>QS/RA Manager, Mettler Electronics Corporation<br>1333 South Claudina Street<br>Anaheim, CA 92805 |
| Date prepared | March 19, 2024 |
| 807.92(a)(2) - Name of device | |
| Trade or proprietary name | accufit |
| Common or usual name | Powered Muscle Stimulator |
| Classification name | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Classification panel | Physical Medicine |
| Regulation | 21 CFR 890.5850 |
| Product Code(s) | IPF, NGX |
| 807.92(a)(3) - Legally marketed device(s) to which equivalence is claimed | |
| Mettler Electronics Corporation K223802 (10/06/2023) Predicate<br>Johari Digital Healthcare Limited K192039 (03/29/2020) Reference<br>Sport- Elec K092476 (05/07/2010) Reference | |
| 807.92(a)(4) - Device description | |
| The principle of operation of the accufit device is to provide direct<br>electrical stimulation of muscles which produces muscle contractions in<br>and around the area of the treatment electrodes.<br><br>The accufit generates electrical stimulation to contract the muscles to<br>achieve the desired intended use using unique IntelliPhase waveforms<br>and IntelliSTIM electrodes. It offers two unique IntelliPhase<br>waveforms, Biphasic and Interferential (4P), that are designed to<br>optimize muscle re-education and activation for patients. The four<br>IntelliPhase waveform protocols are twist, hold, grip, and tap. Each | |
| protocol may be used for 15, 30, or 45 minutes. Not only are there four<br>IntelliPhase protocols, but there is also a fully automated protocol<br>(IntelliCycle) that integrates all the above listed waveforms in a<br>comprehensive, interlaced series. This engages all the targeted muscles<br>in a continuous program to maximize muscle effects with the touch of a<br>button. | |
| accufit is both the proprietary-trade name and generic name. accufit is a<br>supplement to existing treatments and does not replace any traditional<br>treatment or therapy. | |
| The system console is the heart of the accufit and contains the Touch<br>LCD/GUI, electrodes, and power supply module. The main console<br>also includes a key switch used to turn the power on and off, and an<br>emergency stop push button that quickly de-energizes the system in<br>emergency situations. There are 4 casters in the console base that can<br>be used when moving the system. | |
| 807.92(a)(5) Intended use of the device | |
| Indications for use | The accufit is indicated for use for Relaxation of muscle spasms,<br>Prevention or retardation of disuse atrophy, Increase local blood<br>circulation, Muscle re-education, Maintaining or increasing range of<br>motion, Immediate post-surgical stimulation of calf muscles to prevent<br>venous thrombosis, Improvement of abdominal tone, for strengthening<br>of the abdominal muscles, for development of firmer abdomen, and<br>Improvement of muscle tone and firmness, for strengthening muscles in<br>arms, thighs and buttocks areas. |

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| 807.92(a)(6) Summary of the technological characteristics of the device compared to the predicate | | | | | |
|---------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Model Name | accufit | accufit | Torc Body | Body Control<br>System "4M" | Notes |
| 510(k) # | Subject device | K223802 | K192039 | K092476 | |
| Manufacturer | Mettler | Mettler | Johari Digital<br>Healthcare Limited | Sport-Elec S.A | |
| Indications for Use | • Relaxation of muscle<br>spasms<br>• Prevention or<br>retardation of disuse<br>atrophy<br>• Increase local blood<br>circulation<br>• Muscle re-education<br>• Maintaining or<br>increasing range of<br>motion<br>• Immediate post-<br>surgical stimulation of<br>calf muscles to prevent<br>venous thrombosis<br>• Improvement of<br>abdominal tone, for<br>strengthening of the<br>abdominal muscles, for<br>development of firmer<br>abdomen.<br>Improvement of muscle<br>tone and firmness, for<br>strengthening muscles in<br>arms, thighs and<br>buttocks areas. | • Relaxation of muscle<br>spasms<br>• Prevention or<br>retardation of disuse<br>atrophy<br>• Increase local blood<br>circulation<br>• Muscle re-education<br>• Maintaining or<br>increasing range of<br>motion<br>• Immediate post-<br>surgical stimulation of<br>calf muscles to<br>prevent venous<br>thrombosis | • Improvement of<br>abdominal tone, for<br>strengthening of the<br>abdominal muscles,<br>for development of<br>firmer abdomen.<br>• Strengthening, toning<br>and firming of<br>buttocks & thighs. | Improvement of<br>muscle tone and<br>firmness, for<br>strengthening<br>muscles in arms,<br>abdomen, thighs and<br>buttocks areas. | Identical to predicate<br>plus reference<br>devices |
| Classification | 890-5850 - IPF, NGX | 890-5850 - IPF | 890-5850 - NGX | 890-5850 - NGX | Identical to<br>predicate plus<br>reference devices |
| Power Source | 100-240VAC ,<br>50/60Hz, 1.0A (Fuse:<br>250V / 6.3A) | 100-240VAC ,<br>50/60Hz, 1.0A<br>(Fuse: 250V / 6.3A) | 100-240AC,<br>50/60Hz, 75VA | Battery powered | Identical |
| Therapeutic<br>Modality | Electrical muscle<br>stimulator | Electrical muscle<br>stimulator | Electrical muscle<br>stimulator | Electrical muscle<br>stimulator | Identical |
| Treatment Output<br>Mode | Electrode | Electrode | Electrode | Electrode | Identical |
| Method of Line<br>Current<br>Isolation | Double Insulated Wire<br>Non- Conductive<br>Enclosure | Double Insulated<br>Wire Non-<br>Conductive<br>Enclosure | (a) AC Power supply<br>is converted to DC<br>Power supply<br>through a medical<br>grade PSU.<br>(b) Isolation thru<br>transformer in<br>between device and<br>patient | Not available | Same as predicate |
| Measured Patient<br>Leakage: | | | | | |
| Normal Condition<br>(μ Α) | Less than 100μA | Less than 100μA | Less than 100μA | Not available | Identical |
| Single Fault<br>Condition (μΑ) | Less than 100μA | Less than 100μA | Less than 300μA | Not available | Similar |
| Number of Output<br>Modes | 4 | 4 | 3 | Not available | 1 additional mode |
| Number of Output<br>Channels | 2 | 2 | 2 | 2 | Identical |
| Regulated Current<br>or Voltage | Current = 100mA<br>maximum | Current = 100mA<br>maximum | 103.2 mA pp @ 500<br>Ohm 31.2 mA pp @<br>2K Ohm 6.6 mA pp<br>@ 10K Ohm | Not available | Identical when<br>compared at 500<br>Ohm |
| Pulse Intensities | Adjustable, 0-100 mA<br>peak into 500ohm load<br>each Electrode channel | Adjustable, 0-100<br>mA peak into<br>500ohm load each<br>Electrode channel | Not available | Not available | Same as predicate |
| Software/Firmware/<br>Microprocessor<br>Control | yes | yes | yes | Not available | Identical |
| Automatic Over<br>Current Trip? | yes | yes | yes | Not available | Identical |
| Automatic No Load<br>Trip? | yes | yes | no | Not available | Same as predicate |
| Automatic Shut<br>Off? | yes | yes | yes | Not available | Identical |
| User Override<br>control? | Patient Interrupt (Stop)<br>Switch | Patient Interrupt<br>(Stop) Switch | yes | Not available | Identical |
| Indicator Display: | yes | yes | yes | Not available | Identical |
| On/ Off Status? | yes | yes | yes | Not available | Identical |
| Voltage/ Current<br>Level? | yes | yes | yes | Not available | Identical |
| Timer range | 15, 30, 45 mins | 15, 30, 45 mins | 1 – 60 Minutes In<br>step of 1 minute | Not available | Similar |
| Compliance:<br>Voluntary<br>Standards | IEC 60601-1; 60601-<br>1-2; 60601-2-10, ISO<br>14971, UL 60601,<br>CSA C22.2 No 606.1 | IEC 60601-1;<br>60601-1-2; 60601-2-<br>10, ISO 14971, UL<br>60601, CSA C22.2<br>No 606.1 | YES IEC 60601-1,<br>IEC 60601-1-<br>2,IEC60601-2-10,<br>and ISO14971 | Not available | Similar |
| Compliance: 21<br>CFR 898 | yes | yes | yes | Not available | Identical |
| Weight | 27 Kg | 27 Kg | 32.66 Kgs | Not available | Similar |
| Dimensions (mm)<br>W x L x H | 452 x 582 x 1101 | 452 x 582 x 1101 | 444 x 356 x 1016 | 84x126x30 | Similar |
| Housing, Materials<br>and Construction | ABS plastic | ABS plastic | ABS Plastic Body | Not available | Identical |

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| Medical Equipment<br>Classification…