FDA-Cleared Wearable · Pulsed Shortwave Therapy · Available over-the-counter (OTC)
ActiPatch® (1 unit)
FDA 510(k) K192234 · cleared for over-the-counter adjunctive treatment of musculoskeletal pain
FDA-Cleared Wearable · Pulsed Shortwave Therapy · Available over-the-counter (OTC)
ActiPatch® (1 unit)
FDA 510(k) K192234 · cleared for over-the-counter adjunctive treatment of musculoskeletal pain
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ActiPatch® is an FDA 510(k) cleared (K192234), drug-free wearable that delivers pulsed shortwave therapy at 27.12 MHz for over-the-counter adjunctive treatment of musculoskeletal pain. One device provides 720 therapy hours and costs $39.99 at painkiller.care.
How to Use ActiPatch®
Position over pain
Place the device loop directly over the source of your pain.
Secure with tape
Use the included tape to hold the loop in place over the intended area.
Or wear it over a thin layer of clothing. Avoid thick fabric between the device and the skin.
Switch on and follow directions
Press the on/off button, then follow the package directions for use and wear duration.
Product Details
PAINKILLER™ ActiPatch® is an FDA-cleared, drug-free bioelectric pain relief system. Delivers continuous 27.12 MHz Pulsed Short Wave Therapy (PSWT) directly to the source of pain for up to 720 hours. Designed for musculoskeletal conditions like back pain, knee osteoarthritis, neck pain, and plantar fasciitis. Discreet, wearable, and clinically proven — without drugs, opioids, or systemic side effects.
Common uses
- 720 hours of therapy per device
- Drug-free; contains no medicine or active drug ingredient
- No Rx needed; available over-the-counter (OTC)
- Not a TENS unit; a self-contained Pulsed Shortwave Therapy (PSWT) wearable with nothing to connect or manage
Verify the clearance details
ActiPatch's FDA 510(k) number is K192234. You can verify it in the FDA's public 510(k) database. FDA registration or approval language is not the same as 510(k) clearance.
What's Included
Technical Specifications
- Therapy type
- Pulsed Shortwave Therapy
- Frequency
- 27.12 MHz
- Pulse rate
- 1,000 pulses per second
- Treatment area
- 110 cm²
- Operation time
- 720 therapy hours
- Battery
- Integrated CR2032 battery
- Device weight
- 9.5 g
At a Glance
Different from TENS
A self-contained wearable—no electrode pads or lead wires to manage. Designed to operate without perceptible heat or tingling from the device.
Drug-Free
The device contains no medicine or active drug ingredient. Ask a clinician or pharmacist if you have questions about using any device with your current care.
Clearance you can verify
ActiPatch® is cleared for over-the-counter adjunctive treatment of musculoskeletal pain. A 510(k) clearance is a determination of substantial equivalence to a legally marketed device; it is not FDA approval.
View the official record
Open the FDA's public K192234 record and confirm the clearance details directly.
Evidence presented in context
Product and mechanism details on this page stay within the cleared over-the-counter (OTC) indication. Individual experiences vary; product information is not medical advice.