(233 days)
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
The subject device (Model: FM-B2403) is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.
This document is a 510(k) Premarket Notification for a TENS & EMS Device (Model FM-B2403). It outlines the device's characteristics and demonstrates its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, Model SEM44).
It's important to note that this document does not describe a study involving an algorithm or AI. Instead, it focuses on the physical and electrical specifications of a medical device (a TENS and EMS stimulator) and compares them directly to a legally marketed predicate device to establish substantial equivalence for regulatory clearance. Therefore, many of the requested details about acceptance criteria for an AI/algorithm-based device and its study will not be present in this type of submission.
However, I can extract the information relevant to this specific device's acceptance strategy, which relies on demonstrating substantial equivalence to a predicate device through non-clinical testing of its physical and electrical parameters.
Here's a breakdown of the available information based on your request, adapted to the context of this traditional medical device submission:
1. A table of acceptance criteria and the reported device performance
For this type of device, the "acceptance criteria" are not framed as performance metrics against a clinical ground truth for an algorithm. Instead, they are the technical specifications and safety standards measured against the predicate device's characteristics and recognized industry standards. The "reported device performance" is essentially its measured engineering specifications.
The table in Section 7.1 and 7.2 of the 510(k) Summary serves this purpose. The "SE" column indicates "Substantially Equivalent," implying that the subject device's performance (its measured characteristics) meets the criteria for substantial equivalence to the predicate.
| Contents (Acceptance Criteria / Parameter to be met) | Subject Device (Reported Device Performance) | Predicate Device (Target for equivalence) | SE (Outcome of Meeting Criteria) |
|---|---|---|---|
| Basic Characteristic | |||
| Trade Name | TENS & EMS Device | HIVOX OTC Electrical Stimulator | SE |
| Device Model | FM-B2403 | SEM44 | / (Not a direct SE comparison, just identifies) |
| Regulatory Information | 882.5890, 890.5850 | 882.5890, 890.5850 | / (Indicates equivalent regulatory classification) |
| Classification | Class II | Class II | / |
| Product code | NUH, NGX | NUH, NGX | / |
| Panel | Physical Medicine; Neurology | Neurology; Physical Medicine | / |
| OTC/RX | OTC | OTC | / |
| Intended Use | (Identical descriptions for TENS and EMS) | (Identical descriptions for TENS and EMS) | SE |
| Apply parts of the body | Shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom | Shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom | SE |
| Power Source | Built-in 3.7V lithium battery | Batteries, 3x1.5V AAA | SE (Functionally equivalent despite different battery type) |
| Number of Output Modes | TENS:19, EMS:5 | TENS: 15 EMS: 35 | SE (Different numbers, but still acceptable for equivalence) |
| Number of Output Channels | 4 | 2 | SE (More channels is not considered a disadvantage for equivalence) |
| Synchronous or Alternating | Synchronous | Synchronous | SE |
| Method of Channel Isolation | By electrical circuit and software | By electrical circuit and software | SE |
| Regulated Current or Regulated Voltage | Regulated voltage control | Regulated voltage control | SE |
| Software/Firmware/Microprocessor Control? | Yes | Yes | SE |
| Automatic Overload Trip? | No | Yes | SE (Difference noted, but deemed non-critical for substantial equivalence) |
| Automatic No-Load Trip? | No | Yes | SE (Difference noted, but deemed non-critical for substantial equivalence) |
| Automatic Shut Off? | Yes | Yes | SE |
| Patient Override Control? | Yes | Yes | SE |
| Indicator Display? | Yes | Yes | SE |
| Timer Range (minutes) | 10-80 | 5-100 | / (Acceptable range difference for equivalence) |
| Compliance with Voluntary Standards? | ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10 | IEC60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10 | SE |
| Compliance* with 21 CFR 898? | Yes | Yes | SE |
| Weight(g) | 82 g | 89 g (including belt clip, without batteries), 123 g (including belt clip and batteries) | SE |
| Dimensions (mm) [D x W H] | 1106015 | 132 x 63 x 29.5 mm (including belt clip) | SE |
| Housing Materials and Construction | ABS | ABS | SE |
| Output Parameters | (Comparison to Predicate and often to a second predicate for broader range acceptance) | ||
| Waveform | biphasic | biphasic | SE |
| Shape | Square | Square / Rectangular (Second Predicate) | SE |
| Maximum Output Voltage (volts) (+/- 10%) | 97.6@500Ω, 135@2KΩ, 157@10KΩ | 100volts peak-peak±10%@500Ω, 180volts peak-peak±10%@2kΩ, 250volts peak-peak±10%@10KΩ; 62@500Ω (Second Pred.) | SE |
| Maximum Output Current (mA) (+/- 10%) | 195.2@500Ω, 67.5@2KΩ, 15.7@10KΩ | 200mA peak-peak±10% @500Ω, 90mA peak-peak±10% @2kΩ, 25mA peak-peak±10% @10kΩ; 124@500Ω, 37.6@2KΩ (Second Pred.) | SE |
| Pulse Duration (µsec) | 90µS | 50-450µS; 100µS (Second Pred.) | SE |
| Frequency† (Hz) [or Rate† (pps)] |
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).