(238 days)
Not Found
No
The summary describes a device that uses electromagnetic fields for muscle stimulation and does not mention any AI or ML components.
No.
The intended uses listed (improvement of abdominal tone, strengthening of muscles, development of firmer abdomen, strengthening/toning/firming of buttocks/thighs/calves/arms) describe cosmetic or fitness benefits rather than the treatment of diseases or medical conditions, which is the characteristic of a therapeutic device.
No
The device description and intended use clearly state that the NuEra Tight Family, EMS Model, is designed for muscle stimulation, strengthening, toning, and firming, which are therapeutic and aesthetic purposes, not diagnostic ones. It does not mention identifying, monitoring, or predicting medical conditions.
No
The device description explicitly states it "generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large". This indicates the device includes hardware components (the generator and handpieces) that are essential to its function, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description of the NuEra Tight Family, EMS Model, clearly states its function is to "produce an electromagnetic field that induces electrical current in the muscles" for strengthening, toning, and firming. This is a physical interaction with the body, not a test performed on a sample outside the body.
- Intended Use: The intended use is focused on improving muscle tone and firmness, not on diagnosing or detecting any medical condition through analysis of biological samples.
The information provided describes a device used for physical therapy or aesthetic purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NuEra Tight Family, EMS Model, is intended for:
- improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- strengthening, toning and firming of buttocks, thighs and calves;
- improvement of muscle tone and firmness, for strengthening muscles in arms.
Product codes
NGX
Device Description
NuEra Tight Family, EMS Model, is a family of devices designed to:
- produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Abdomen, buttocks, thighs, calves, arms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electrical safety and electro-magnetic compatibility:
The NuEra Tight Family, EMS Model, has been tested and is in compliance with:
- IEC 60601-1; Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- IEC 60601-1-2; Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests;
- IEC 60601-1-6; Medical Electrical Equipment Part 1-6: General Requirements For Basic Safety And ● Essential Performance - Collateral Standard: Usability;
- IEC 60601-2-10/A1; Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators;
- IEC 62304; Medical Device - Software Life Cycle Processes;
- ISO 14971; Medical Devices Application Of Risk Management To Medical Devices.
Software Verification and Validation:
Software verification was conducted to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification was also performed on the NuEra Tight Family, EMS Model, in compliance with internal design control procedures. The results of this testing conclude the NuEra Tight Family, EMS Model, is determined to be safe and effective.
Functional Testing:
Functional tests have been performed to confirm that the performance of the NuEra Tight Family, EMS Model, devices are aligned with the device technical specifications.
Biocompatibility:
Based on the type and duration of body contact, existing biocompatibility data has been assessed in accordance with ISO 10993-1:2018 (FDA standards recognition # 2-258) and FDA guidance document 'Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and Food and Drug Administration Staff', 16 June 2016.
The NuEra Tight Family, EMS Model, has no contact with the skin of the treated patients.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
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.(b)
Classification. Class II (performance standards).
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December 31, 2020
Bios s.r.l. Maurizio Bianchi Head of QA/RA Via Guido Rossa 10/12 Vimodrone, MI 20090 Italy
Re: K201239
Trade/Device Name: NuEra Tight Family, EMS Model Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 5, 2020 Received: October 8, 2020
Dear Maurizio Bianchi:
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
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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 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-devices/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 (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,
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201239
Device Name NuEra Tight Family, EMS Model
Indications for Use (Describe)
| The NuEra Tight Family, EMS Model, is intended for: | |
|---|---|
| ----------------------------------------------------- | -- |
-
improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
-
strengthening, toning and firming of buttocks, thighs and calves;
-
improvement of muscle tone and firmness, for strengthening muscles in arms.
| 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
| Contact Details | |
|---|---|
| 510(k) Number | K201239 |
| 510(k) Type | Traditional |
| Applicant Information | Bios s.r.l. |
| Via Guido Rossa, 10/12 | |
| 20090 Vimodrone (MI) – Italy | |
| Contact | Dr Eliana Russo |
| Date Prepared | 24 June 2020 |
| Device Name(s): | NuEra Tight Family, EMS Model |
| Model Refs | APMD151 |
| Common Name | Powered Muscle Stimulator |
| Regulatory Class | Class II |
| Product Codes | NGX |
| Regulation Names | Stimulator, muscle, powered, for muscle conditioning |
| Predicate Device for EMS Treatments | |||
|---|---|---|---|
| K190456 | NGX, 890.5850 | Powered Muscle Stimulator (BTL 799-2L) | BTL Industries, Inc. |
Device Description
NuEra Tight Family, EMS Model, is a family of devices designed to:
- produce an electromagnetic field that induces electrical current in the muscles. By muscle stimulation, the system helps to strengthen, tone and firm the abdomen, buttocks, thighs and calves.
The device belonging to the NuEra Tight Family, EMS Model, generates an intense magnetic field which is used to stimulate muscles trough two EMS handpieces, one small and one large, which can treat body parts of different sizes.
Indications for Use
The NuEra Tight Family, EMS Model, is intended for:
- . Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen;
- ı Strengthening, toning and firming of buttocks, thighs and calves;
- . Improvement of muscle tone and firmness, for strengthening muscles in arms.
Predicate Device Comparison
The product specification, functionality, indications for use, and treatment parameters of the NuEra Tight Family, EMS Model, are the same or very similar to the legally marketed predicate and reference devices.
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For the electromagnetic stimulation function, the subject device and predicate device have many identical, similar or substantially equivalent properties or features. No differences that could affect safety or effectiveness have been identified, as indicated in Table 1.
| Table 1: Predicate device comparison table – NuEra Tight Family, EMS Model – Electromagnetic Stimulation | |||
|---|---|---|---|
| Feature | Subject device | Predicate device | Similarity |
| Device name | NuEra Tight Family (EMS Model) | BTL 799-2L | N/A |
| Device Manufacturer | Bios S.r.l. | BTL Industries, Inc. | N/A |
| 510(K) Number | K201239 | K190456 | N/A |
| Product Code | NGX - Stimulator, Muscle, Powered | NGX - Stimulator, Muscle, Powered | Same |
| Regulation | 21 CFR 890.5850 | 21 CFR 890.5850 | Same |
| Indications for Use | The NuEra Tight Family (EMS Model) is intended: | ||
| • for improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen; | |||
| • for strengthening, toning and firming of buttocks, thighs and calves; | |||
| • for improvement of muscle tone and firmness, for strengthening muscles in arms. | BTL 799-2L is indicated to be used for: | ||
| • Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. | |||
| • Strengthening, toning and firming of buttocks, thighs and calves. | |||
| • Improvement of muscle tone and firmness, for strengthening muscles in arms. | Same | ||
| Principle of action | Initiating action potential of nerves results in muscle contraction. | Initiating action potential of nerves results in muscle contraction. | Same |
| Clinical use | Prescription Use | Prescription Use | Same |
| Electrical Protection | Class I type BF | Class I type BF | Same |
| User Interface | Touch Screen | Touch Screen | Same |
| Firmware Controlled | Yes | Yes | Same |
| Type of energy | Magnetic Field | Magnetic Field | Same |
| Number of outputs | 2 | 2 | Same |
| Number of magnetic | |||
| coils in the applicator | 1 | 1 | Same |
| Magnetic Field Intensity | Large HP: 0.5 – 1.8 T ± 20% | BTL 299-6 applicator: 0.5 - 1.8 T ± 20% | Same |
| Small HP: 0.7 – 2.0 T ± 20% | BTL 299-7 applicator: 0.7 - 2.0 T ± 20% | Same | |
| Pulse Repetition Rate | 1-150 Hz | 1-150 Hz | Same |
| Pulse Duration | Large HP: 280 ± 20% µs | BTL 299-6 applicator: 280 ± 20% µs | Same |
| Small HP: 190 ± 20% µs | BTL 299-7 applicator: 190 ± 20% µs | Same | |
| Therapy Time | Up to 60 min | Up to 60 min | Same |
| Characteristics | Bios Device | Predicate Device | Notes |
| Device name | NuEra Tight Family (EMS Model) | BTL 799-2L | N/A |
| Device Manufacturer | Bios s.r.l. | BTL Industries, Inc. | N/A |
| 510(K) Number | K201239 | K190456 | N/A |
| Power Source(s) |
- Method of Line
Current Isolation
Patient Leakage
Current - Normal condition
- Single fault condition | IEC 60601-1 compliant