STIMPOD NMS460 Nerve Stimulator
Device Facts
| Record ID | K252712 |
|---|---|
| Device Name | STIMPOD NMS460 Nerve Stimulator |
| Applicant | Algiamed Technologies USA, Inc. |
| Product Code | GZJ · Neurology |
| Decision Date | May 28, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain conditions. The device is also used as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain problems, as well as adjunct for pain control due to rehabilitation. The device provides temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities.
Device Story
Handheld, low-frequency TENS device; delivers electrical impulses to peripheral nerves for pain relief. Inputs: user-selected stimulation parameters via control dial. Operation: generates monophasic square wave or hybrid RF waveform (monophasic square wave with superimposed 130kHz sinusoidal burst). Output: focused current-controlled stimulation (1-30mA, 1-10Hz, 100-200μs pulse width) via surface electrode. Used in clinical or rehabilitation settings; operated by healthcare professionals. Output provides symptomatic pain relief; aids in management of chronic, post-surgical, post-traumatic, and diabetic neuropathic pain. Features automatic overload, no-load detection, and shut-off for safety.
Clinical Evidence
Single-blind, randomized, prospective, placebo-controlled study. Primary endpoint: Douleur Neuropathique 4 (DN4) scores; secondary endpoint: Brief Pain Inventory (BPI) worst pain severity. Assessments at post-treatment, 1, 3, and 6 months. Results showed statistically significant reduction in neuropathic pain in active group vs. placebo. No procedure- or device-related adverse events reported.
Technological Characteristics
Handheld TENS device; ABS plastic housing; SSt 316L electrodes. Power: 4x AAA batteries. Waveforms: Monophasic square wave and Hybrid RF (130kHz sinusoidal burst). Output: 1-30mA, 1-10Hz, 100/200μs pulse width. Load impedance 0-7.0 kOhm. Features LED display, control dial, and automatic safety detection (overload/no-load/shut-off). Class IIa, Type BF.
Indications for Use
Indicated for patients with chronic intractable pain, post-surgical pain, post-traumatic acute pain, or pain requiring rehabilitation. Also indicated for temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities. Contraindicated in patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic/electronic devices, and patients with undiagnosed pain syndromes.
Regulatory Classification
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.
Predicate Devices
- STIMPOD NMS460 Nerve Stimulator (K161091)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 28, 2026
Algiamed Technologies USA, Inc.
Irina Proutski
Regulatory Affairs Consultant
801 International Pkwy. 5th Floor
Lake Mary, Florida 32746
Re: K252712
Trade/Device Name: STIMPOD NMS460 Nerve Stimulator
Regulation Number: 21 CFR 882.5890
Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
Regulatory Class: Class II
Product Code: GZJ
Dated: December 15, 2025
Received: December 15, 2025
Dear Irina Proutski:
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 (the 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 available 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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K252712 - Irina Proutski
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assistance/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,
For Amber Ballard, PhD
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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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K252712 | |
| Device Name STIMPOD NMS460 Nerve Stimulator | |
| Indications for Use (Describe) The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain conditions. The device is also used as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain problems, as well as adjunct for pain control due to rehabilitation. The device provides temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities. | |
| 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) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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ALGIAMED
# 510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with requirements of 21 CFR 807.87 and 807.92.
# 1. Submitter
Date prepared 28 May 2026
Name Algiamed Technologies USA Inc
Address 801 International Pkwy 5th Floor
Lake Mary, FL 32746
United States
Contact Person Irina Proutski
Contact e-mail irina@algiamed.com
# 2. Device
Device Name STIMPOD NMS460 Nerve Stimulator
Classification Name Transcutaneous Electrical Nerve Stimulator
(21 CFR 882.5890)
Device Class Class II
Product code GZJ
# 3. Predicate Device
Model Name STIMPOD NMS460 Nerve Stimulator
Manufacturer Xavant Technology (Pty) Ltdt
Submission Number K161091
Classification Name Transcutaneous Electrical Nerve Stimulator
(21 CFR 882.5890)
Device Class Class II
Product code GZJ
# 4. Device Description
The STIMPOD NMS460 is a handheld, low frequency neuromodulation Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain, as well as an adjunct for pain control due to rehabilitation exercises.
The STIMPOD NMS460 offers two types of waveforms for the management of pain. The first is a Monophasic Square Wave, which is typical of normal TENS machines. The second waveform is a Hybrid RF waveform which consists of a Monophasic Square Wave with a superimposed Radio Frequency waveform.
The device is provided with a stimulation cable, conductive electrode gel and a printed copy of the Instructions for Use. The stimulation cable is a point-contact surface electrode intended for use during stimulation sessions to target and stimulate specific nerves. A nerve fiber is excited through the focused current controlled delivery of a patented stimulation pattern that consists of high frequency, shaped sinusoidal burst at 130kHz with a stimulation pulse width of 100μs and 200μs, intensity (1mA – 30mA) and repetition rate (1Hz – 10Hz).
STIMPOD NMS460 Nerve Stimulator 510(k)
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ALGIAMED
# 5. Indications for Use
The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for symptomatic relief and management of chronic intractable pain conditions.
The device is also used as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain problems, as well as adjunct for pain control due to rehabilitation.
The device provides temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities.
# 6. Comparison of Technological Characteristics with the Predicate Device
The subject device has identical intended use, technological characteristics, mechanism of action and operating principles compared to the predicate device. Both the subject and the predicate devices utilize an application of electrical current to stimulate peripheral nerves to achieve pain relief. Both devices offer the same two types of waveforms for the management of pain. The subject device has nearly identical output specifications as the predicate device – high frequency, shaped sinusoidal burst at 130kHz with a stimulation pulse width of 100μs and 200μs, intensity (1mA – 30mA) and repetition rate (1Hz – 10Hz). The purpose of this submission is to include a specific indication for use (management of neuropathic pain due to diabetic neuropathy). The electrical stimulation parameters and other characteristics have not changed between the devices.
| Characteristics | NMS460 (subject device) | NMS460 (primary device) | Substantial equivalence |
| --- | --- | --- | --- |
| 510(k) | K252712 | K161091 | |
| Manufacturer | Algiamed Technologies USA Inc | Xavant Technology (Pty) Ltd | Different. The 510(k) for the device was transferred from Xavant Technology (Pty) Ltd to Algiamed Technologies USA Inc in 2025. |
| | | | |
| Intended Use/ Indications for Use statement | | | |
| Intended Use | The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device that uses electrical impulses to stimulate a nerve of interest and relieve the pain. | The STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device that uses electrical impulses to stimulate a nerve of interest and relieve the pain. | same |
| Indications for Use | The STIMPOD NMS460 is a Transcutaneous Electrical Nerve Stimulation device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic pain problems, as well as an adjunct for pain control due to rehabilitation. The device provides temporary relief of mild to | The STIMPOD NMS460 is a Transcutaneous Electrical Nerve Stimulation device used for symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical pain, post traumatic pain problems, as well as an adjunct for pain control due to rehabilitation. | Different. The Indications for Use statement of the STIMPOD NMS460 is not identical to that of the predicate device. The only difference is the inclusion of “temporary relief of mild to moderate neuropathic pain |
STIMPOD NMS460 Nerve Stimulator 510(k)
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ALGIAMED
| | moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities. | | associated with diabetic peripheral neuropathy of the lower extremities,” which is supported by clinical data. The difference does not alter the intended therapeutic use of the device (transcutaneous electrical stimulation of peripheral nerves for pain relief), nor does it raise different questions of safety or effectiveness relative to the predicate. Both the subject and predicate devices have the same intended use of symptomatic relief and management of pain through delivery of short-term electrical stimulation |
| --- | --- | --- | --- |
| Rx vs OTC | Prescription Use | Prescription Use | same |
| Contraindications | • Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device, because this may cause electric shock, burns, electrical interference, or death • Do not use this device on patients whose pain syndromes are undiagnosed | • Known neurological disorders • Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device, because this may cause electric shock, burns, electrical interference, or death • Do not use this device on patients whose pain syndromes are undiagnosed | Different. Removal of this contraindication does not lead to different questions of safety or effectiveness |
| Single use electrodes | Yes | Yes | same |
| | | | |
| Technological Characteristics | | | |
STIMPOD NMS460 Nerve Stimulator 510(k)
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ALGIAMED
| Electrical classification | IEC 60601-1 | IEC 60601-1 | same |
| --- | --- | --- | --- |
| Device classification | Class IIa, Type BF | Class IIa, Type BF | same |
| Product dimensions | 145mm x 90mm x 30mm | 145mm x 90mm x 30mm | same |
| Power supply | 4 x AAA alkaline batteries | 4 x AAA alkaline batteries | same |
| Power consumption | 17mA | 17mA | same |
| Stimulating Frequency | 1, 2, 5 and 10Hz | 1, 2, 5 and 10Hz | same |
| Waveform | Monophasic square wave and Hybrid RF (monophasic square wave with a superimposed Radio Frequency waveform) | Monophasic square wave and Hybrid RF (monophasic square wave with a superimposed Radio Frequency waveform) | same |
| Load impedance | 0 – 7.0 kOhm | 0 – 7.0kOhm | same |
| Current range | 0 – 30mA | 0 – 30mA | same |
| Pulse width | 0.1ms, 0.2ms | 0.1ms, 0.2ms | same |
| Controls | Control dial | Control dial | same |
| Output regulation | Device software and control dial | Device software and control dial | same |
| Number of output modes | 1 | 1 | same |
| Number of waveforms | 2 | 2 | same |
| Number of output channels | 1 | 1 | same |
| Automatic overload detection | Yes | Yes | same |
| Automatic no-load detection | Yes | Yes | same |
| Automatic shut-off | Yes | Yes | same |
| User Override control | Yes | Yes | same |
| Device display | LED screen | LED screen | same |
| Device materials | ABC plastic | ABC plastic | same |
| Electrode materials | SSt 316L | SSt 316L | same |
| Current/voltage source | Current source | Current source | same |
| Maximum stimulation voltage | 220V | 220V | same |
| Maximum output current | 43.7mA | 43.7mA | same |
| Maximum average current (over primary phase) | 29.85mA | 29.85mA | same |
| Duration of primary phase | 206μs | 206μs | same |
| Pulse duration | 206μs | 206μs | same |
| Maximum average phase charge | 6.06μC @500 Ohm | 6.06μC @500 Ohm | same |
| Net charge | 6.06μC | 6.06μC | same |
| Maximum current density | 93.28μA/mm² @500 Ohm | 93.28μA/mm² @500Ohm | same |
| Maximum average power density | 71.5μW/mm² @500 Ohm 591.8μW/mm² @5 kOhm | 71.5μW/mm² @500 Ohm 591.8μW/mm² @5 kOhm | same |
| Treatment timer maximum | 99min | 99min | Same |
STIMPOD NMS460 Nerve Stimulator 510(k)
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ALGIAMED
## 7. Performance Data
### Non-Clinical
No non-clinical testing has been conducted for the subject device because non-clinical testing was conducted for the predicate device (K161091), which included electrical safety, electromagnetic compatibility, biocompatibility evaluation and software verification and validation. As no technological changes have been made to the subject device, no additional non-clinical performance testing is required in this submission.
### Clinical Data
Safety and effectiveness of STIMPOD NMS460 for temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities is supported by a single-blind, randomized, prospective, placebo-controlled clinical study.
The primary effectiveness endpoint was a validated neuropathic pain assessment tool - Douleur Neuropathique 4 scores, and the secondary effectiveness endpoint was Brief Pain Inventory worst pain severity scores. The primary and secondary effectiveness endpoints were assessed immediately post-treatment and at 1, 3 and 6-month follow-up.
The study demonstrated a statistically significant reduction in neuropathic pain in the active treatment group compared to placebo. The treatment effect on pain severity was confirmed to be independent of baseline patient characteristics. The study did not report any procedure- or device-related adverse events.
## 8. Conclusion
The STIMPOD NMS460 Nerve Stimulator has the same technological characteristics as the predicate device (K161091), no technological changes have been made. The Intended Use of the subject device is as same as the predicate device. A new indication (temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy of the lower extremities) was supported by clinical data and does not raise different questions of safety or effectiveness. It can be concluded that STIMPOD NMS460 Nerve Stimulator is substantially equivalent to the identified predicate device (K161091).
STIMPOD NMS460 Nerve Stimulator 510(k)
