(597 days)
BEMER therapy systems (BEMER Classic Set, BEMER Pro-Set) are indicated for:
- To temporarily increase local blood circulation in healthy leg muscles
- To stimulate healthy muscles in order to improve and facilitate muscle performance
BEMER therapy systems are a family of noninvasive physical medicine devices that can be used as a supportive therapy to increase local blood circulation. BEMER therapy is offered in two system options-Classic and Professional. Both systems consist of a B.BOX console, a set of BEMER signal applicators, power pack, B.SCAN indicator and accessories for attachment. The B.PAD and B.SPOT applicators have been cleared for use in this submission.
BEMER systems improve local blood distribution via electromagnetic stimulatory principles. The resulting increase in local blood distribution can broadly benefit patients. The indications for use allow the application to increase local blood circulation or stimulate healthy muscles in order to improve and facilitate muscle performance.
Acceptance Criteria and Device Performance:
The provided document is a 510(k) summary for the BEMER Classic Set and BEMER Pro-Set. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit acceptance criteria with specific performance metrics for the BEMER device itself.
However, the "Performance Testing" section states that "BEMER therapy systems are compliant with the following standards and have outputs that are within the same range as the predicate devices". This implies that the 'acceptance criteria' for the BEMER device's performance are that it meets these standards and operates within a comparable range to the predicate.
The "Technical and Performance Comparison" table (Table 12.1) details the comparison between the BEMER Therapy Systems (Subject Device) and the predicate device (Revitive IX, K143207) and a reference device (Neotonus MS-101 Magnetic Muscle Stimulator System, K973929).
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, direct acceptance criteria with specific numerical thresholds for increased blood circulation or improved muscle performance are not provided. Instead, the acceptance is based on demonstrating substantial equivalence by meeting regulatory standards and having comparable technical characteristics and functionality to the predicate device.
| Feature / Criteria (Implied) | Predicate Device (Revitive IX, K143207) Performance | Subject Device (BEMER Therapy Systems) Performance | Comparison Comments (from document) |
|---|---|---|---|
| Indications for Use (Key Acceptance) | - Temporarily increase local blood circulation in healthy leg muscles. |
- Stimulate healthy muscles to improve/facilitate muscle performance. | - Temporarily increase local blood circulation in healthy leg muscles.
- Stimulate healthy muscles to improve/facilitate muscle performance. | Same/Substantially Equivalent |
| Mode of Action | Non-invasive tissue stimulation via skin electrodes. | Non-invasive tissue stimulation via magnetic field induction. | "Effectiveness: As the mode of action differs from direct induction (predicate device) to indirect induction (subject device), safety and effectiveness must be proven via a comparative series of measurements" |
| Waveform | Pulsed symmetrical, constant amplitude during treatment. | Pulsed asymmetric, constant amplitude during treatment. | Minor difference, no impact on safety and effectiveness. |
| Shape | Rectangular, bipolar. | Sinusoidal, monopolar. | Minor difference, no impact on safety and effectiveness. |
| Pulse repetition rate | Foot: 20-53Hz; Body: 35-46Hz. | All accessories: 10-30Hz. | Minor difference, no impact on safety and effectiveness. |
| Single pulse duration | Foot: 0.4 - 7.5µS; Body: 1.4 - 33.6µS. | All accessories: 10 - 33µS. | Minor difference, no impact on safety and effectiveness. |
| Maximum Power density applied | Foot: 0.023 mA/cm2; Body: 0.082 mA/cm2. | All accessories: 35 - 100μT. | Minor difference, no impact on safety and effectiveness. |
| Maximum output voltage | @500Ω: 20-32V; @2kΩ: 95-118V; @10kΩ: 138-169V. | N/A (Does not directly apply voltage). | "Safety: The subject device does not directly apply voltage to the human body. Therefore, no new hazards were identified." |
| Maximum Output Current (directly applied) | @500Ω: 40-64mA; @2kΩ: 48-59mA; @10kΩ: 14-17mA. | All accessories:
§ 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).