Everything a premarket notification needs, in one place: which device you are clearing, which cleared device it is compared against, the wording of the claim, and the sections that must be in the package.
Predicate: [K number of a cleared OTC TENS predicate you select]
DiaPulse cannot be a predicate here. Substantial equivalence needs the same technological characteristics, and the pod produces a low-frequency electrical pulse through electrodes — no radiofrequency field at all. A TENS submission must cite a cleared TENS predicate.
Worth being blunt: DiaPulse is not a usable predicate for the pod. It is a 27.12 MHz radiofrequency machine, and the pod is an electrical stimulator with no radiofrequency output at all — a reviewer would reject the comparison. Cite DiaPulse when you clear the radiofrequency applicator; for the pod, cite a cleared TENS device.
510(k) PREMARKET NOTIFICATION — SUBSTANTIAL EQUIVALENCE WORKBOOK Prepared 2026-09-18 Submitter: [submitter legal name] Contact: [contact person, phone, email] Address: [establishment address] 1. SUBJECT DEVICE Trade name: [device trade name] Common name: [common or usual name] Device family: DOMAS-class wireless TENS / EMS pod Regulation: 21 CFR 882.5890 — transcutaneous electrical nerve stimulator for pain relief Classification: Class II, powered electrical stimulator 2. PREDICATE DEVICE Predicate: [K number of a cleared OTC TENS predicate you select] Predicate 510(k) number: [K number] Basis: DiaPulse cannot be a predicate here. Substantial equivalence needs the same technological characteristics, and the pod produces a low-frequency electrical pulse through electrodes — no radiofrequency field at all. A TENS submission must cite a cleared TENS predicate. 3. INDICATIONS FOR USE [indications for use statement] 4. TECHNOLOGICAL CHARACTERISTICS COMPARED - Low-frequency pulsed electrical stimulation through adhesive electrodes - Twelve factory preset programs; the app selects a preset number, never a waveform - Intensity 1–20 and run time 1–60 minutes, both clamped by the pod's own firmware - Charge per pulse and charge density from Amendment A bench measurement - Indication sought: symptomatic relief of chronic intractable pain and pain associated with arthritis 5. DIFFERENCES FROM THE PREDICATE [differences and the testing that addresses them] 6. OUTPUT MEASUREMENT Measured output is reported in Amendment A, the bench dosimetry record for this device. Published literature values are not used as device output. 7. CLINICAL SUPPORT — PILOT STUDY ENDPOINTS Pulsed radiofrequency energy for postoperative pain and edema after elective foot and ankle surgery: a randomised, double-blind, sham-controlled pilot Design: Randomised 1:1, double-blind, sham-controlled pilot study, 40 participants. Primary endpoint: Ankle edema at day 7, measured by the figure-of-eight tape method on both ankles, reported as the difference from the unoperated side. Secondary endpoints: - Pain on the 0–10 numeric rating scale at each follow-up point. - Analgesic consumption, recorded as daily morphine milligram equivalents. - WOMAC pain subscale score at day 30. - Wound surface area from photo planimetry, where a wound is present. - Adverse events and device-related events across the 30 days. Assessment schedule: 1 hour, 24 hours, Day 3, Day 7, Day 14, Day 30. Measurement rule: Tape measurement repeats to roughly ±3 mm at a limb landmark, so a change smaller than 3 mm is treated as measurement noise, not a result. Statistical note: the pilot estimates effect size to size a pivotal trial. It is not powered to demonstrate efficacy, and is presented on that basis. 8. SECTION CHECKLIST [ ] Cover letter and CDRH cover sheet (Form FDA 3514) [ ] Indications for use statement (Form FDA 3881) [ ] 510(k) summary and substantial equivalence discussion [ ] Truthful and accurate statement [ ] Device description, components and accessories [ ] Proposed labelling, instructions for use and safety warnings [ ] Biocompatibility of skin-contacting materials (ISO 10993) [ ] Electrical safety and EMC testing (IEC 60601-1, 60601-1-2) [ ] Output measurement report — Amendment A bench dosimetry [ ] Software documentation and cybersecurity (app as the controller) [ ] Human factors and use-related risk analysis [ ] Shelf life and reprocessing of electrode pads, where applicable [ ] Clinical data — pilot study report, if clinical data is required
This workbook organises your submission; it is not a substitute for regulatory advice, and the K number, testing reports and labelling still have to be prepared and reviewed.