(30 days)
The BioWaveGO Rx is indicated for prescription use for:
· Symptomatic relief of chronic, intractable pain
· Symptomatic relief of acute pain
· As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain
The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME. The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.
This FDA 510(k) summary for the BioWaveGO Rx device does not contain a typical acceptance criteria table and performance study results. Instead, it focuses on demonstrating substantial equivalence to a predicate device (BioWaveGO, K180943) through a comparison of specifications.
The document explicitly states: "No additional testing was required for this Special 510(k)." This indicates that a new performance study with acceptance criteria was not conducted for the BioWaveGO Rx as part of this submission because it is deemed substantially equivalent in performance to its predicate. The substantial equivalence is based on the device being identical in design and indications to the predicate, with the only change being its availability for prescription use rather than over-the-counter.
Therefore, many of the requested elements for a performance study are not applicable or cannot be extracted from this document, as a specific new performance study wasn't part of this 510(k) submission.
Despite the lack of a dedicated performance study for this specific submission, I can present the information that is available and explain the context:
1. Acceptance Criteria and Reported Device Performance
As no new performance study was conducted, there are no specific acceptance criteria or reported device performance results from a new study presented in this document. The "performance" assessment is by comparison to the predicate device, asserting that its performance is equivalent due to identical design and function. The acceptance criteria, in this context, would be that the BioWaveGO Rx device demonstrates substantial equivalence to its predicate across all specified characteristics.
The table below summarizes the comparison points that implicitly serve as "performance" metrics for substantial equivalence:
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (BioWaveGO Rx) | Outcome |
|---|---|---|---|
| Indications for Use | - Symptomatic relief of chronic, intractable pain- Symptomatic relief of acute pain- As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain | - Symptomatic relief of chronic, intractable pain- Symptomatic relief of acute pain- As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain | Identical |
| Connectivity | Bluetooth Capable: YesSmartphone Interface: Yes | Bluetooth Capable: YesSmartphone Interface: Yes | Identical |
| Regulatory Classification (Use) | Prescription (similar to BioWaveHOME reference device) / Over-the-Counter (BioWaveGO predicate) | Prescription | Similar (Aligns with reference, differentiates from predicate, but justified by professional oversight) |
| Power Source | One 3.2V 1100mAh rechargeable lithium iron phosphate battery | One 3.2V 1100mAh rechargeable lithium iron phosphate battery | Identical (to BioWaveGO predicate) |
| Line Current Isolation | Battery + interlocks | Battery + interlocks | Identical |
| Patient Leakage Current | None | None | Identical |
| Number of Output Modes/Channels | One / One | One / One | Identical |
| Output Regulation | Regulated Voltage | Regulated Voltage | Identical |
| Software/Firmware/Microprocessor Control | Yes | Yes | Identical |
| Safety Features | Automatic Overload Trip: Yes (software)Automatic No-Load Trip: Yes (software)Automatic Shut Off: YesPatient Override Control: YesMany safety interlocks | Automatic Overload Trip: Yes (software)Automatic No-Load Trip: Yes (software)Automatic Shut Off: YesPatient Override Control: YesMany safety interlocks | Identical |
| Indicator Display | On/Off Status: YesLow Battery: YesVoltage/Current Level: Yes (% of full scale) | On/Off Status: YesLow Battery: YesVoltage/Current Level: Yes (% of full scale) | Identical |
| Timer Range | 30 minutes | 30 minutes | Identical |
| Compliance with Standards | Voluntary Standards: Yes21 CFR 898: Yes | Voluntary Standards: Yes21 CFR 898: Yes | Identical |
| Physical Dimensions | Weight: 6 ouncesDimensions: 3.0" x 4.0" x 1.0" | Weight: 6 ouncesDimensions: 3.0" x 4.0" x 1.0" | Identical (to BioWaveGO predicate) |
| Housing Materials | ABS via conventional injection molding | ABS via conventional injection molding | Identical |
| Waveform/Shape | Biphasic / Sum of 2 sine waves | Biphasic / Sum of 2 sine waves | Identical |
| Maximum Output Voltage | 80V p-p @ 500 Ω (20 V AC RMS) (BioWaveGO predicate) | 80V p-p @ 500 Ω (20 V AC RMS) | Identical (to BioWaveGO predicate) |
| Maximum Output Current | 160mA p-p @ 500 Ω (40mA RMS) (BioWaveGO predicate) | 160mA p-p @ 500 Ω (40mA RMS) | Identical (to BioWaveGO predicate) |
| Pulse Width | Continuous modulation | Continuous modulation | Identical |
| Frequency (Hz) | 4062 Hz + 3940 Hz (BioWaveGO predicate) | 4062 Hz + 3940 Hz | Equivalence based on frequency difference (to BioWaveHOME) |
| Beat Frequency (Hz) | 122 Hz | 122 Hz | Identical |
| Net Charge (mC per pulse) | 0 @ 500 Ω (biphasic - AC coupled continuous wave) | 0 @ 500 Ω (biphasic - AC coupled continuous wave) | Identical |
| Maximum Current Density | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
| Maximum Power Density | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |
2. Sample size used for the test set and the data provenance
Not applicable. As stated, "No additional testing was required for this Special 510(k)." The evidence for substantial equivalence relies on the existing clearance of the predicate device (BioWaveGO, K180943) and a reference device (BioWaveHOME, K152437), not a new clinical or performance test set for the BioWaveGO Rx.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new human-read test set was established. This submission is a comparison of technical specifications against previously cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was part of this submission.
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
Not applicable. The device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic imaging device or a device involving human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical neuromodulation device, not an algorithm, and its performance is inherent to its electrical stimulation characteristics, not a standalone algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the BioWaveGO Rx, the "ground truth" for its substantial equivalence claim is the demonstrated safety and efficacy of its predicate device (BioWaveGO, K180943), which previously underwent its own regulatory clearance process. The current submission's "ground truth" is that the new device largely mirrors the predicate's technical and performance characteristics.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
February 24, 2021
BioWave Corporation % Dave Mcgurl Director, Regulatory Affairs Mcra LLC 1050 K Street NW Suite 1000 Washington, District of Columbia 20001
Re: K210202
Trade/Device Name: BioWaveGO RX Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: January 12, 2021 Received: January 25, 2021
Dear Dave Mcgurl:
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
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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 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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jitendra Virani Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210202
Device Name BioWaveGO Rx
Indications for Use (Describe)
The BioWaveGO Rx is indicated for prescription use for:
· Symptomatic relief of chronic, intractable pain
· Symptomatic relief of acute pain
· As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Device Trade Name: | BioWaveGO Rx System |
|---|---|
| Manufacturer: | BioWave Corporation8 Knight Street, Suite 201Norwalk, CT 06851 |
| Contact: | Bradford SiffFounder & PresidentBioWave Corporation8 Knight Street, Suite 201Norwalk, CT 06851Phone: 203-247-9020Fax: 203-286-2518brad.siff@biowave.com |
| Prepared by: | Mr. Dave McGurlDirector, Regulatory AffairsMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Office: 202.552.5797Fax: 202.552.5798dmcgurl@mcra.com |
| Date Prepared: | February 24, 2021 |
| Regulation Number: | 21 CFR §882.5890 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator For Pain Relief |
| Regulatory Class: | II |
| Product Code: | GZJ |
Indications for Use:
The BioWaveGO Rx is indicated for prescription use for:
- · Symptomatic relief of chronic, intractable pain
- Symptomatic relief of acute pain
- · As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain
Device Description:
The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME.
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The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.
Predicate Device:
BioWave Corporation's BioWaveGO Neuromodulation Pain Therapy Device is substantially equivalent to the predicates previously cleared with respect to indications, design, function, and materials, as outlined below.
| Manufacturer | Device Name | K-Number |
|---|---|---|
| BioWave Corporation | BioWaveGO | K180943 (primary predicate) |
| BioWave Corporation | BioWaveHOME | K152437 (reference device) |
Performance Testing Summary:
No additional testing was required for this Special 510(k).
Substantial Equivalence:
The subject device, the BioWaveGO Rx, was demonstrated to be substantially equivalent to the primary predicate device cited in the table above with respect to indications, design, materials, function, manufacturing, and/or performance and to the predicate devices with respect to availability (i.e. prescription) and indications. The subject device is identical in indications and design. The only difference is to make the device available as a prescription use device. There is no additional risk as a healthcare professional would be prescribing the device to the patient.
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| Predicate Comparison Table | ||||
|---|---|---|---|---|
| Subject DeviceBioWaveGO Rx Device | Primary Predicate DeviceBioWaveGO OTC Device | Reference DeviceBioWaveHOME Device | Comparison | |
| Manufacturer | BioWave Corporation | BioWave Corporation | BioWave Corporation | - |
| Trade Name | BioWaveGO Rx | BioWaveGO | BioWaveHOME | - |
| 510(k) | K210202 (subject) | K180943 | K152437 | Identical. Both the primarypredicate and subject devicehave Bluetooth. |
| Bluetooth Capable | Yes | Yes | No | Identical. Both the primarypredicate and subject devicehave Bluetooth. |
| Smartphone Interface | Yes | Yes | No | Identical. Both the primarypredicate and subject devicehave a smart phone interface. |
| Prescription or Over-the-Counter | Prescription | Over-the-Counter | Prescription | Similar. The primary predicateis for OTC use. The referenceand subject devices are forprescription use. |
| Image | Image: BioWaveGO | Image: BioWaveGO | Image: BioWaveHOME | - |
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| Subject DeviceBioWaveGO Rx Device | Primary Predicate DeviceBioWaveGO OTC Device | Reference DeviceBioWaveHOME Device | Comparison | |
|---|---|---|---|---|
| The BioWaveGO RxNeuromodulation PainTherapy Device is indicatedfor prescription use for: | The BioWaveGONeuromodulation Pain TherapyDevice is indicated for over-the-counter use for: | The BioWaveHOMENeuromodulation Pain TherapyDevice is indicated forprescription use for: | ||
| Indications | - Symptomatic relief ofchronic, intractable pain- Symptomatic relief of acutepain- As an adjunctive treatment inthe management of post-surgical and post-traumaticacute pain | - Symptomatic relief of chronic,intractable pain- Symptomatic relief of acutepain- As an adjunctive treatmentin the management of post-surgical and post-traumaticacute pain | - Symptomatic relief ofchronic, intractable pain, post-surgical, and post-traumaticacute pain- Symptomatic relief of acutepain- Symptomatic relief of post-operative pain | Identical. The indications foruse are the same as theprimary predicate. |
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| Device Name, Model | BioWave CorporationBioWaveGO RX Device(Subject) | BioWave CorporationBioWaveGO Device (K180943) | BioWave CorporationBioWaveHOME Device(K152437) | Comparison |
|---|---|---|---|---|
| BioWaveGO Rx | BioWaveGO | BioWaveHOME | - | |
| Manufacturer | BioWave Corporation | BioWave Corporation | BioWave Corporation | - |
| Power Source(s) | one 3.2V 1100mAh rechargeablelithium iron phosphate battery | one 3.2V 1100mAh rechargeablelithium iron phosphate battery | two 3.2V 3300mAhrechargeable lithium ironphosphate batteries | Identical(BioWaveGO only) |
| Method of Line Current Isolation | Battery + interlocks | Battery + interlocks | Battery + interlocks | Identical |
| Patient Leakage Current | None | None | None | Identical |
| Normal condition | None | None | None | Identical |
| Single fault condition | None | None | None | Identical |
| Number of Output Modes | One | One | One | Identical |
| Number of Output Channels | One | One | One | Identical |
| Synchronous or Alternating? | N/A | N/A | N/A | - |
| Method of Channel Isolation | N/A | N/A | N/A | - |
| Regulated Current or RegulatedVoltage? | Regulated Voltage | Regulated Voltage | Regulated Voltage | Identical |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Yes | Identical |
| Automatic Overload Trip? | Yes (software) | Yes (software) | Yes (software) | Identical |
| Automatic No-Load Trip? | Yes (software) | Yes (software) | Yes (software) | Identical |
| Automatic Shut Off? | Yes | Yes | Yes | Identical |
| Patient Override Control? | Yes | Yes | Yes | Identical |
| Indicator Display: | Yes | Yes | Yes | Identical |
| On/Off Status? | Yes | Yes | Yes | Identical |
| Low Battery? | Yes | Yes | Yes | Identical |
| Voltage/Current Level? | Yes (% of full scale) | Yes (% of full scale) | Yes (% of full scale) | Identical |
| Timer Range - (minutes) | 30 | 30 | 30 | Identical |
| Compliance with VoluntaryStandards? | Yes | Yes | Yes | Identical |
| Compliance with 21 CFR 898? | Yes | Yes | Yes | Identical |
| Weight | 6 ounces | 6 ounces | 1.0 lbs | Identical(BioWaveGO only) |
| BioWave CorporationBioWaveGO RX Device(Subject) | BioWave CorporationBioWaveGO Device (K180943) | BioWave CorporationBioWaveHOME Device(K152437) | Comparison | |
| Dimensions (in.) (W x H x D) | 3.0" x"4.0" x 1.0" | 3.0" x"4.0" x 1.0" | 3.75" x 6.0" x 1.75" | Identical(BioWaveGO only) |
| Housing Materials and Construction | ABS via conventional injectionmolding | ABS via conventional injectionmolding | ABS via conventionalinjection molding | Identical |
Comparison of Basic Unit Characteristics for BioWayeHOME (K152437) and RioWayeGO (K180943)
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Comparison of Output Specifications for BioWaveGO Rx to BioWaveHOME (K152437) and BioWaveGO (K180943)
| BioWave CorporationBioWaveGO Rx Device(Subject) | BioWave CorporationBioWaveGO Device(K180943) | Parent BioWave CorporationBioWaveHOME Device(K152437) | Comparison | |
|---|---|---|---|---|
| Waveform | Biphasic | Biphasic | Biphasic | Identical |
| Shape | Sum of 2 sine waves | Sum of 2 sine waves | Sum of 2 sine waves | Identical |
| Maximum Output Voltage Available(+1-2%) (with software calibrationcorrection) | 80V p-p @ 500 Ω20 V AC RMS | 80V p-p @ 500 Ω20 V AC RMS | 110V p-p @ 500 Ω27.5 V AC RMS | Identical(BioWaveGO only)BioWaveGO Rx offers adecreased maximumvoltage compared toBioWaveHOME |
| Maximum Output Current (+1- 2%) (current depends on load) | 160mA p-p @ 500 Ω40mA RMS40 mA p-p @ 2kΩTrip out @ 10kΩ | 160mA p-p @ 500 Ω40mA RMS40 mA p-p @ 2kΩTrip out @ 10kΩ | 220mA p-p @ 500 Ω55mA RMS55 mA p-p @ 2kΩTrip out @ 10kΩ | Identical(BioWaveGO only)BioWaveGO Rx has alower maximum currentdensity compared toBioWaveHOME. |
| Pulse Width | Continuous modulation | Continuous modulation | Continuous modulation | Identical |
| Frequency (Hz) | 4062 Hz + 3940 Hz | 4062 Hz + 3940 Hz | 3980 Hz + 3858 Hz | Equivalence based onfrequency difference |
| For interferential modes only:- Beat Frequency (Hz) | 122 Hz | 122 Hz | 122 Hz | Identical |
| For multiphasic waveforms only:- Symmetrical phases?- Phase Duration | N/AN/A | N/AN/A | N/AN/A | - |
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| BioWave CorporationBioWaveGO Rx Device(Subject) | BioWave CorporationBioWaveGO Device(K180943) | Parent BioWave CorporationBioWaveHOME Device(K152437) | Comparison | |
|---|---|---|---|---|
| Net Charge (m C per pulse) (If zero,state method of achieving zero netcharge.) | 0 @ 500 Ωbiphasic - AC coupledcontinuous wave | 0 @ 500 Ωbiphasic - AC coupledcontinuous wave | 0 @ 500 Ωbiphasic - AC coupledcontinuous wave | Identical |
| Maximum Phase Charge, (μ C) | N/A | N/A | N/A | - |
| Maximum Current Density,(µmA/cm²)(with 1.375" diam pad = 9.58 cm2area) | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
| Maximum Power Density, (W/cm²)(using 1.375" diam 9.58 cm² electrodeconductive surface area) | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |
| Burst Modea. Pulses per burstb. Bursts per secondc. Burst duration (seconds)d. Duty Cycle [Line (b) x Line (c)] | N/A | N/A | N/A | - |
| ON Time (seconds) | N/A | N/A | N/A | - |
| OFF Time (seconds) | N/A | N/A | N/A | - |
| Additional Features (if applicable) | Many safety interlocks: cableconnected to unit, padsconnected to cable, padsconnected to body, max powerdensity, battery ok fortreatment, charger connected(trip off) | Many safety interlocks: cableconnected to unit, padsconnected to cable, padsconnected to body, max powerdensity, battery ok fortreatment, charger connected(trip off) | Many safety interlocks: cableconnected to unit, padsconnected to cable, padsconnected to body, max powerdensity, battery ok for treatment,charger connected (trip off) | Identical |
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Conclusion:
The BioWaveGO Rx device has been found to be substantially equivalent to the previously cleared predicate device, BioWaveGO, with respect to its intended use, design, function, materials, and performance.
§ 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).