(326 days)
FDES106 (ED406) Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in order to improve and facilitate muscle performance.
FDES106A (ED406A) Multi-function Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance.
FDES105 (ED405) Pain Relief Plaster
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
FDES107 (ED407) Abdominal Fitness Belt
Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.
The FDES106(ED406) Series Stimulator, which includes models FDES106(ED406), FDES106A(ED406A), FDES105(ED405) and FDES107(ED407), are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The device unit of FDES106(ED406) and FDES106A(ED406A) are same, only the applied part are different: the applied part of FDES106(ED406) is electrode pad; the applied part of FDES106A(ED406A) is electrode belt. They are portable device, battery powered (3.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The FDES106 (ED406) includes FDE$105 (ED405). FDES106 (ED406) has TENS and EMS two treatment mode 5 programs (N, B, H, E1, E2), FDES105 (ED405) only has TENS mode 5 treatment programs (N1, N2, B, H, F).Their appearance, structure, circuit, software operation is exactly the same, only different output treatment procedure.
FDES107 (ED407) has 10 EMS treatment process, whose intended use, waveform characteristics and is basically the same as FDES106 (ED406) EMS model, The difference is from only operation mode and structure appearance.
Independent channel (by electrode pad or electrode belt) that effectively transfers your desired choice of pre-programmed electrical pulses directly through electrode pad or electrode belt) to suggested area of the body where the electrode are placed, causing minimal muscle contractions. The FDES106 (ED406 ) and FDES106A (ED406A ) have 3 TENS programs and 2 EMS programs; FDES105 (ED405) have 5 TENS programs; FDES107 (ED107) have 10 EMS programs.
The provided document is a 510(k) premarket notification for the Famidoc FDES106 Series Electro-Stimulator devices (including models FDES106, FDES106A, FDES105, and FDES107). It aims to demonstrate substantial equivalence to legally marketed predicate devices.
Critical Note: This document explicitly states: "The FDES106(ED406) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there are no acceptance criteria based on clinical performance metrics (like sensitivity, specificity, accuracy), nor is there any study related to device performance in a clinical context reported within this document. The "acceptance criteria" and "device performance" in this context refer to adherence to established electrical, mechanical, and biocompatibility safety standards.
Below is an analysis based on the information provided regarding the non-clinical tests and comparisons.
Acceptance Criteria and Study to Demonstrate Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for an electro-stimulator, the acceptance criteria are generally based on compliance with recognized safety and performance standards for such devices, and substantial equivalence to predicate devices. The "reported device performance" refers to the device's adherence to these standards and its characteristics as compared to the predicates.
| Acceptance Criterion (Standard or Characteristic) | Reported Device Performance (Compliance / Comparison) |
|---|---|
| Safety Standards Compliance | |
| IEC 60601-1 (General safety) | Compliant |
| IEC 60601-1-2 (EMC) | Compliant |
| IEC 60601-1-11 (Home healthcare environment) | Compliant |
| IEC 60601-1-4 (Programmable electrical medical systems) | Compliant |
| IEC 60601-2-10 (Nerve and muscle stimulators safety) | Compliant |
| Biocompatibility Standards Compliance | |
| ISO 10993-5 (Cytotoxicity) | Compliant for electrode pad/belt and ABS enclosure materials |
| ISO 10993-10 (Irritation and skin sensitization) | Compliant for electrode pad/belt and ABS enclosure materials |
| Software Verification | Carried out according to FDA software guidance. |
| Electrical Output Specifications | Compared to predicate devices (T1040™ and Slenderton FLEX Abdominal Training System type 515), the new devices demonstrate similar waveform (Biphasic square), Max Output Voltage, Max Output Current, Pulse Width, Maximum Current Density, Maximum Average Current, Maximum Power Density, Maximum Average Power Density, and Duration of primary phase. Details are provided in tables in the submission (e.g., Pages 9-11). The differences are presented as not affecting intended use or equivalence. |
| Mechanical Features & Design | Compared to predicate devices, devices are internally powered equipment, have Type BF applied part protection, are Class II devices, and have similar features regarding output channels, treatment programs, materials of construction, automatic safety features (e.g., over current trip, no load trip, shut off time), and physical dimensions/weight. The differences are detailed in tables (e.g., Pages 5-8). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Description: The "test set" in this context refers to the Famidoc FDES106 Series devices themselves, which underwent non-clinical (bench) testing.
- Sample Size: The document does not specify a quantitative sample size for the bench testing (e.g., "N units were tested"). It describes the tests generally applied to the device series. It is implied that representative units of each model (FDES106, FDES106A, FDES105, FDES107) were tested to demonstrate compliance.
- Data Provenance:
- Country of Origin: The test results are presumably from China, where the manufacturer (Famidoc Technology Co., Ltd.) is located.
- Retrospective or Prospective: The testing described is prospective, in the sense that the devices were tested against established standards to support the premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Ground Truth Establishment: For non-clinical device safety and performance testing, "ground truth" is established by recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FDA software guidance). These standards represent a consensus among experts (engineers, medical professionals, regulatory bodies) over years of development and revision.
- Number of Experts: Not applicable in the sense of individual expert review for each test outcome. Compliance is assessed against the defined requirements of the standards.
- Qualifications of Experts: The experts involved are those who developed and maintain the relevant IEC and ISO standards, and FDA guidance documents. Their qualifications would typically include extensive experience in electrical engineering, biomedical engineering, materials science, toxicology, and regulatory affairs pertaining to medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The "adjudication" for non-clinical testing refers to the objective measurement of device parameters against the defined limits or requirements of the standard. There is no human subjective adjudication of the test results themselves, beyond internal quality control and regulatory review for compliance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This is not an imaging or diagnostic device that relies on human readers interpreting results, nor does it incorporate AI. The device is an electro-stimulator for pain relief and muscle conditioning.
- Effect Size of AI: Not applicable, as there is no AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is a physical medical device (electro-stimulator), not a software-only algorithm. The "software verification" mentioned confirms the software functions as designed and complies with FDA guidance, but it's not a standalone performance study in the sense of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this submission is compliance with international safety and performance standards (IEC, ISO) and FDA software guidance. This reflects an expert consensus on what constitutes a safe and acceptably performing electro-stimulator. The claims of "substantial equivalence" are based on comparing the device's characteristics to those of legally marketed predicate devices, which themselves have met these regulatory standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set.
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510(k) SUMMARY [As required by 21CFR 807.92]
FEB - 7 2014
FDES106(ED406) Series Electro-Stimulator, K (130723 )
Submitter's Information [21CFR 807.92(a)(1)] 1.
| Company Name: | Famidoc Technology Co., Ltd |
|---|---|
| Street Address: | No. 212 Yilong Road, Hexi Industrial Zone, Jingxia, Changan |
| Town | |
| City: | Dongguan |
| State/ Province: | Guangdong |
| Country: | China |
| Telephone: | +86(769) 89272488-8674 |
| Fax: | +86(769) 89272498 |
| Contact Person: | Reanny Wang |
| Contact Title: | Vice-general Manager |
| Contact Email: | qa@famidoc.com |
2. Trade Name, Common Name, Classification [21CFR 807.92(a)(2)]
| a) Trade Name: | FDES106(ED406) Mini TENS&EMS DeviceFDES106A(ED406A) Multi-function TENS&EMS Device |
|---|---|
| Common Name: | Electro-Stimulator or Electrical Stimulator |
| Classification Name: | Stimulator, Muscle, Powered, for muscle conditioningper 21 CFR § 890.5850;Transcutaneous Electrical Nerve Stimulator for Pain Relief;Stimulator, Nerve, Transcutaneous, Over-the-Counterper 21 CFR § 882.5890 |
| Device Class: | Class II |
| Product Code: | NUH, NGX |
Section 07-Page 1 of 13
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| b) Trade Name: | FDES105(ED405) Pain Relief Plaster |
|---|---|
| Common Name: | TENS or TENS Device |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator for Pain ReliefStimulator, Nerve, Transcutaneous, Over-the-Counterper 21 CFR § 882.5890 |
| Device Class: | Class II |
| Product Code: | NUH |
| c) Trade Name: | FDES107(ED407) Abdominal Fitness Belt |
| Common Name: | Powered Muscle Stimulator, OTC |
| Classification Name: | Stimulator, Muscle, Powered, for muscle conditioningper 21 CFR § 890.5850; |
| Device Class: | Class II |
| Product Code: | NGX |
-
- Identification of Predicate Device(s)[21 CFR 807.92(a)(3)]
| PREDICATE DEVICES | ||
|---|---|---|
| Manufacturer | Endurance Therapeutics | Bio-Medical ResearchLtd |
| Legally Marketed Device | T1040™ | Slenderton FLEXAbdominal Trainingsystem type 515 |
| 510 (K) Number | K060846 | K030708 |
Description of Device[21 CFR 807.92(a)(4)] 4.
The FDES106(ED406) Series Stimulator, which includes models FDES106(ED406), FDES106A(ED406A), FDES105(ED405) and FDES107(ED407), are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
{2}------------------------------------------------
The device unit of FDES106(ED406) and FDES106A(ED406A) are same, only the applied part are different: the applied part of FDES106(ED406) is electrode pad; the applied part of FDES106A(ED406A) is electrode belt. They are portable device, battery powered (3.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The FDES106 (ED406) includes FDE$105 (ED405). FDES106 (ED406) has TENS and EMS two treatment mode 5 programs (N, B, H, E1, E2), FDES105 (ED405) only has TENS mode 5 treatment programs (N1, N2, B, H, F).Their appearance, structure, circuit, software operation is exactly the same, only different output treatment procedure.
FDES107 (ED407) has 10 EMS treatment process, whose intended use, waveform characteristics and is basically the same as FDES106 (ED406) EMS model, The difference is from only operation mode and structure appearance.
Independent channel (by electrode pad or electrode belt) that effectively transfers your desired choice of pre-programmed electrical pulses directly through electrode pad or electrode belt) to suggested area of the body where the electrode are placed, causing minimal muscle contractions. The FDES106 (ED406 ) and FDES106A (ED406A ) have 3 TENS programs and 2 EMS programs; FDES105 (ED405) have 5 TENS programs; FDES107 (ED107) have 10 EMS programs.
5. Intended Use[21 CFR 807.92(a)(5)] FDES106(ED406) Mini TENS &EMS Device
For program N, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in order to improve and facilitate muscle performance.
{3}------------------------------------------------
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FDES106A(ED406A) Multi-function Mini TENS &EMS Device
For program N, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh and arm due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in the lower back, abdomen, thigh and arm in order to improve and facilitate muscle performance.
FDES105(ED405) Pain Relief Plaster
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
FDES107(ED407) Abdominal Fitness Belt
Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.
6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: [21 CFR 807.92(a)(6)]
The FDES106(ED406) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:
-
IEC 60601-1, Medical electrical equipment Part 1: General requirements for safety".
-
IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility- Requirements and tests, Interpretation Sheet."
-
IEC 60601-1-11, Medical electrical equipment Part 1-11: General Requirements for basic safety and essential performance - Collateral Standard: Requirements for
Section 07-Page 4 of 13
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medical electrical equipment and medical electrical systems used in the home healthcare environment.
-
IEC 60601-1-4, Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
-
IEC 60601-2-10, Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators
-
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
7. Biocompatibility Certification for accessories [21 CFR 807.92(a)(7)]
The materials of applied part are Electrode pad and Electrode belt; the material of enclose is ABS. They are both meet the biocompatibility testing of ISO 10993-5 and ISO 10993-10 standards.
8. Comparison for Predicate Device & Subject Device [21 CFR 807.92(a)(8)}
We present the relevant information for the predicate device here for demonstrating the characteristics of the predicate device.
8.1 Comparison of significant device features
{5}------------------------------------------------
Sponsor: Famidoc Technology Co., Ltd.
File No: XVV-Stimulator A-FDA-07
Version: 1.2
Data: Feb.7, 2014
| Comparison item | Mini TENS&EMS DeviceFDES106 | Multi-functionMini TENS&EMS DeviceFDES106A | PainReliefPlasterFDES105 | New deviceAbdominal FitnessBelt FDES107 | Predicate deviceT1040™ | Predicate deviceSlenderton FLEXAbdominal Trainingsystem type 515 |
|---|---|---|---|---|---|---|
| 510K# | Pending | K060846 | K030708 | |||
| Manufacturer | Famidoc Technology Co., Ltd. | EnduranceTherapeutics | Bio-MedicalResearch Ltd | |||
| Prescription or OTC | OTC | OTC | OTC | |||
| FDA product code | NUH, NGX | NUH | NGX | NUH, NGX | NGX | |
| Power source | Battery powered, d.c. 3.0V, 2 X AAAbatteries | Battery powered, d.c. 4.5V, 3 X AAA batteries | ||||
| User interface | By LED light and silk-screen indication | By LCD display | ||||
| Output channel | Single channel | Two channels | ||||
| Number of output models | TENS and EMS | TENS | EMS | TENS andPMS(EMS) | EMS | |
| Number of treatment programs | 5 | 5 | 10 | 10 | 7 | |
| Number ofoutput channels | Alternating | Alternating | SymmetricalBiphasic | |||
| Number of output channels | 1 | 1 | Dual | |||
| Method of channel isolation | By electrical circuit and software | By electrical circuit and software | ||||
| Constant Current or Constant Voltage? | Constant Voltage | Constant Voltage | ||||
| Waveform | Biphasic square | Biphasic | ||||
| Software/Firmware/ MicroprocessorControl? | Yes | Yes |
Section 07-Page 6 of
Section 07-page 69
{6}------------------------------------------------
nsor: Famidoc Technology
No: XW-Stimulator A-FDAersion: 1.2
ata: Feb.7, 201
amidoc
Slenderton FLE)
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ction 07-Page 7
Section 07-Page 2
{7}------------------------------------------------
nsor: Famidoc Technology Co.,
No: XW-Stimulator A-FDA-07 Version: 1.2
Data: Feb.7, 201
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tion 07-Page 8
{8}------------------------------------------------
Sponsor: Famidoc Technology Co., Ltd.
File No: XVV-Stimulator A-FDA-07
Version: 1.2
Data: Feb.7, 2014
| Comparison item | New device | Predicate device | ||||
|---|---|---|---|---|---|---|
| Mini TENS&EMS DeviceFDES106 | Multi-functionMini TENS&EMS DeviceFDES106A | Pain ReliefPlasterFDES105 | AbdominalFitness BeltFDES107 | T1040™ | Slenderton FLEXAbdominal Trainingsystem type 515 | |
| Classification | Type of protectionagainst electric shock | Internally powered equipment | Internally powered equipment | |||
| Degree of protectionagainst electric shock | Type BF applied part | Type BF applied part | ||||
| Device Class | Class II | Class II | ||||
| Biocompatibility | Compliant with requirements of ISO 10993-5 and ISO 10993-10 | Same | Same | |||
| Compliancewith | Mechanical Safety | Compliant with requirements of IEC 60601-1, IEC 60601-2-10 | Same | Same | ||
| VoluntaryStandards? | Electrical Safety | Compliant with requirements of IEC 60601-1, IEC 60601-2-10,IEC 60601-1-2 safety standards | Same | Same | ||
| Energy delivered | The delivered energy is limited according to requirements ofcollateral IEC 60601-2-10 safety standards | Same | Same | |||
| Other | Compliant with requirements of IEC 60601-11 safety standard | Unknowable | Unknowable | |||
| Applied part | Electrode pad | Electrodebelt | Electrodepad | Abdominalelectrode belt | Abdominalelectrode belt | |
| Weight (lbs., oz.) | 0.093 | 0.093 | 0.093 | 0.18 | 0.19 | |
| Dimensions(in.) [W × H × D]For unit | 2.25"×1.77"×0.36" | 3.62"×3.19"×0.75" | 5.91"x2.68"x1.02" | |||
| Unknowable | ||||||
| Unknowable |
Section 07-Page 9 of
{9}------------------------------------------------
Sponsor: Famidoc Technology Co., Ltd.
File No: XVV-Stimulator A-FDA-07
Version: 1.2
Data: Feb.7, 2014
| Comparison item | Mini TENS&EMS DeviceFDES106 | Multi-functionMini TENS&EMS DeviceFDES106A | Pain ReliefPlasterFDES105 | AbdominalFitness BeltFDES107 | New device | T1040™ | Abdominal TrainingSlenderton FLEXsystem type 515 | Predicate device |
|---|---|---|---|---|---|---|---|---|
| Operating temperature andhumidity | 5-40°C, 30%-85% | Unknowable | 0-35°C, 20%-65% | |||||
| Storage temperature and humidity | -10-50°C, 10%-90% | Unknowable | 0-52°C, 10%-90% |
8.2 Comparison of significant output specifications
| Comparison item | New device | Predicate device | |||||
|---|---|---|---|---|---|---|---|
| Mini TENS&EMS DeviceFDES106 | Multi-functionMini TENS&EMS DeviceFDES106A | Pain ReliefPlasterFDES105 | AbdominalFitness BeltFDES107 | T1040™ | Slenderton FLEXAbdominal Trainingsystem type 515 | ||
| Waveform | TENS mode | Biphasic | Biphasic | Biphasic | N/A | Biphasic | N/A |
| EMS mode | Biphasic | Biphasic | N/A | Biphasic | Biphasic | Biphasic | |
| Shape | TENS mode | Square | Square | Square | N/A | Square | N/A |
| EMS mode | Square | Square | N/A | Square | Square | Square | |
| Max Output Voltage (V) | TENS mode | 30.4 | 30.4 | 28 | N/A | 40.7 | N/A |
| 500Ω load | EMS mode | 28 | 28 | N/A | 46.4 | 40.7 | 47.3 |
| 2kΩload | TENS mode | 44.8 | 44.8 | 36.8 | N/A | 105.1 | N/A |
| EMS mode | 44.8 | 44.8 | N/A | 72 | 105.1 | 89.3 |
Section 07-Page 10 of
{10}------------------------------------------------
nsor: Famidoc Technology No: XW-Stimulator A-Fl ersion: 1.2
ata: Feb.7, 201
Slenderton FLE)
bdominal Traini ystem type 51 Inknowable 200-300 45-75 28.41 91.3 94.7 89.3 60.7 n/A N/A n/A N/A N/A N/A N/A N/A redicate device 1040 T 4.1-50 4.1-50 154.1 47.8 47.8 15.4 15.4 154. 81.4 81.4 245 245 40.7 40.7 2.71 2.71 Fitness Bel Abdomina FDES10 92.8 3-80 23.2 23.2 120 N/A N/A 250 N/A N/A N/A N/A N/A N/A ਰੇ ਟ ਮ Pain Relie FDES10: 00-25 Plaste 41.6 15.2 15.2 18.4 2-80 N/A N/A N/A n/A 4.2 N/A N/A N/A N/A ്ക് New devic ulti-functior EMS Devic Mini TENS FDES106 00-250 60.8 22.4 15.2 15.2 54.4 54.4 22.4 2-80 2-50 5.4 5.4 250 す す റ്റ് ni TENS& MS Device
FDES106 00-25 15.2 54.4 54.4 60.8 22.4 22.4 2-80 2-50 5.2 5.4 5.4 250 56 ম す ENS mode ENS mode ENS mode ENS mod ENS mod ENS mod ENS mod ENS mod MS mode MS mode MS mode MS mode MS mode MS mode MS mode EMS mode omparison ite x Output Current (mA) Maximum Phas ulse cycle (ut let Charge pe equency(H: Charge (uC Pulse Widt Range(uS 00Ω load 0kΩ load 0kΩ load kQload 2000) 500Ω
tion 07-Page 1
amido
{11}------------------------------------------------
Sponsor: Famidoc Technology Co., Ltd.
File No: XVV-Stimulator A-FDA-07
Version: 1.2
Data: Feb.7, 2014
| Comparison item | Mini TENS&EMS DeviceFDES106 | Multi-functionMini TENS&EMS DeviceFDES106A | Pain ReliefPlasterFDES105 | AbdominalFitness BeltFDES107 | T1040™ | Slenderton FLEXAbdominal Trainingsystem type 515 | |
|---|---|---|---|---|---|---|---|
| Maximum Current Density(mA/cm², 500Ω, r.m.s) | TENS mode | 4.1 | 3.4 | 4.1 | N/A | 2.71 | N/A |
| EMS mode | 3.77 | 3.13 | N/A | 1.9 | 2.71 | Unknowable | |
| Maximum AverageCurrent (average absolutevalue) [mA, 500Ω] | TENS mode | 0.51 | 0.42 | 0.48 | N/A | Unknowable | N/A |
| EMS mode | 0.41 | 0.34 | N/A | 0.3 | Unknowable | Unknowable | |
| Maximum Power Density(W/cm², 500Ω, r.m.s) | TENS mode | 0.124 | 0.103 | 0.105 | N/A | 0.099 | N/A |
| EMS mode | 0.105 | 0.087 | N/A | 0.039 | 0.099 | Unknown | |
| Maximum Average PowerDensity (mW/cm²) [usingsmallest electrodeconductive surface area] | TENS mode | 2 | 1.4 | 1.7 | N/A | 5.35 | N/A |
| EMS mode | 1.2 | 1 | N/A | 1.8 | 5.35 | Unknowable | |
| Duration of primary(depolarizing) phase (ms) | TENS mode | 0.25 | 0.25 | 0.25 | N/A | 0.5 | N/A |
| EMS mode | 0.25 | 0.25 | N/A | 0.25 | 0.5 | 0.3 | |
| Burst Mode (For TENS mode only) | |||||||
| a. Pulse per burst | 7 | 7 | 7 | N/A | N/A | N/A | |
| b. Bursts per second | 2 | 2 | 2 | N/A | N/A | N/A | |
| c. Burst duration (ms) | 0.2 | 0.2 | 0.2 | N/A | N/A | N/A | |
| d. Duty Cycle (ms) | 1.4 | 1.4 | 1.4 | N/A | N/A | N/A | |
| Comparison item | New device | Predicate device | |||||
| Mini TENSEMS DeviceFDES106 | Multi-functionMini TENS&EMS DeviceFDES106A | Pain ReliefPlasterFDES105 | AbdominalFitness BeltFDES107 | T1040™ | Slenderton FLEXAbdominal Trainingsystem type 515 | ||
| For EMS mode only | |||||||
| On Time (S) | 5 | 5 | N/A | 4-8 | N/A | Unknowable | |
| Off Time (S) | 10 | 10 | N/A | 2-10 | N/A | Unknowable | |
| Ramp up time(S) | 2 | 2 | N/A | 2-10 | N/A | Unknowable | |
| Ramp down time(S) | 2 | 2 | N/A | 0-12 | N/A | Unknowable |
Section 07-Page 12 of 13
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sor: Famidoc Technolog No: XW-Stimulator A-Fl Data: Feb.7, 201 ersion: 1.2
Conclusion कं
ndamental scientific technology of the device. Thus, the FDES106(ED406) Series Electro-Stimulator is substantially equivalent t ES106(ED406) Series Stimulator, which includes models FDES106A(ED406A) and FDES107(ED407 tended use and technological characteristics and the similar technological characteristics as the predicate device T1040 lendertion FLEX Abdominal Training system type 515 (K030708). Moreover, bench testing, safety report and Risk Analysi umentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same ectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use oredicate device
ction 07-Page 13
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EPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2014
Famidoc Technology Co., Ltd. c/o Reanny Wang Vice-General Manager No. 212 Yilong Road, Hexi Industrial Zone, Jingxia, Changan Town, Dongguan 523853, Guangdong Province CHINA
Re: K130723
Trade Name: FDES106 (ED406) Series OTC Stimulator Models: Mini TENS&EMS Device Model FDES106 (ED406), Multi-function Mini TENS&EMS Device Model FDES106A (ED406A), Pain Relief Plaster Model FDES105 (ED405), Abdominal Fitness Belt Model FDES107 (ED407) Regulation Number: 21 CFR 890.5850
Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II
Product Code: NGX, NUH
Dated: January 7, 2014
Received: January 13, 2014
Dear Mr. Wang:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pemal-S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K130723
FDES106 Series OTC Stimulator Models: Device Name: Mini TENS&EMS Device Model FDES106 (ED406), Multi-function Mini TENS&EMS Device Model FDES106A (ED406A), Pain Relief Plaster Model FDES105 (ED405), Abdominal Fitness Belt Model FDES107 (ED407),
Indications For Use:
FDES106 (ED406) Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in order to improve and facilitate muscle performance.
FDES106A (ED406A) Multi-function Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance.
FDES105 (ED405) Pain Relief Plaster
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
Page 1 of 2
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FDES107 (ED407) Abdominal Fitness Belt
Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR .
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
.
Carlos L.JRenia -S
Page 2 of 2
§ 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).