KYMIRA Infrared Safety & Compliance for Elite Sport
KYMIRA® Infrared: Safe, Regulated, and Approved for All Levels of Global Elite Sport
FDA‑Determined Infrared, Competition‑Approved, Non‑Electronic Performance Textiles
Elite teams across the world rely on KYMIRA because our infrared fabrics meet stringent safety, regulatory and competition requirements.
KYMIRA® garments are powered by CELLIANT® infrared technology, which the U.S. Food & Drug Administration (FDA) has formally determined to be both a medical device and a general wellness product under Section 201(h) of the Federal Food, Drug and Cosmetic Act.
This means KYMIRA® infrared textiles:
- Are non‑powered, non‑electronic fabrics
- Contain no active or prohibited components
- Are classified as clothing, not equipment
- Are safe for daily use, match play and competitive environments
KYMIRA has been safely used in NFL, NBA, MLB, NHL, World Rugby, Premiership Rugby, Olympic programmes, NCAA teams and more without regulatory restriction.
1. Regulatory Status & Medical Safety
CELLIANT® infrared fibers—the engine of KYMIRA® technology—are FDA‑determined medical devices and general wellness products.
This determination is based on their intended effect on local blood flow and tissue oxygenation in healthy individuals, and their classification as low‑risk, non‑thermal, non‑powered textiles.
The FDA has determined that KYMIRA® infrared products containing Celliant® are medical devices as defined in section 201(h) of the Federal Food, Drug and Cosmetic Act and are general wellness products. In the United States, the FDA has determined that Celliant® products are medical devices and are general wellness products. In Canada, the United Kingdom, the European Union, Australia, New Zealand and Japan, Celliant® is designated as a Class 1 Medical Device.
KYMIRA products are CE approved.
Not a Therapeutic Device
The FDA determination does not constitute clearance or approval, nor does it classify the garments as therapeutic or diagnostic equipment.
This ensures full eligibility under competition rules, with no elevation into regulated device status.
2. Safe Under All Anti‑Doping Regulations
KYMIRA® Infrared fabrics:
- Do not release any substances
- Do not alter physiology in a pharmacological way
- Do not interact with WADA‑prohibited lists
- Have zero chemical transfer risks
Our fabrics work by absorbing body heat and re‑emitting infrared energy, not by adding any foreign agents or stimulants.
This makes KYMIRA® fully compliant with WADA, USADA, UKAD, NADA and other international anti‑doping authorities.
3. Approved for All Tier‑1 Competition Environments
KYMIRA® garments meet kit and equipment rules across global professional sport.
This includes:
- NFL
- NBA
- MLB
- NHL
- NCAA
- EPL & European Football
- World Rugby
- International Athletics & Olympic sport
Our products are classified as standard performance clothing, not equipment requiring disclosure or approval.
4. No Electronics. No Risk. No Sanctions.
Teams often seek assurance around unauthorised electronics or smart-device violations.
KYMIRA® Infrared fabrics:
- Contain no batteries, sensors, transmitters or microelectronics
- Do not store or transmit data
- Cannot interfere with GPS, HR monitors or player‑worn sensors
- Are fully compatible with wearable technologies (WHOOP, Catapult, Polar, Oura, Hawkin Dynamics, VALD)
This ensures zero risk of competition sanctions and full compliance with all device policies.
5. No Heat Generation, No Thermal Risk
Infrared fabrics used by KYMIRA® are non‑thermal.
They use photochemical infrared reflection, not heat emission.
The technology:
- Does not elevate tissue temperature
- Does not increase risk in hot‑weather events
- Remains stable under contact, collisions and layering
Infrared output is produced purely from body‑emitted heat, not external heating sources.
6. No Compression Classification Issues
KYMIRA® garments:
- Are not medical‑grade compression
- Are not classified as compression equipment
- Can be freely worn under team kit with no approval required
This is especially important in leagues with strict uniform regulations, such as NFL, NCAA, World Rugby and Premier League football.
*Please note the Infrared Compression socks do have medical grade compression in.
7. Proven Clinical Safety
KYMIRA infrared textiles have undergone:
- Multiple human clinical studies on blood flow and tissue oxygenation
- Safety evaluations across sport, wellness and medical settings
- No adverse effects reported in trials
Clinical publications and FDA guidance confirm low‑risk, non‑invasive, non‑thermal operation
8. Skin safe materials & no chemical treatments
KYMIRA uses bio‑ceramic minerals permanently locked inside the yarn, not surface treatments. This eliminates risks of rubbing, flaking, or chemical transfer, making the garments suitable for sensitive‑skin users.
KYMIRA® Safety Summary
KYMIRA® Infrared Safety Status
✔ FDA‑determined Medical Device & General Wellness Product
✔ No electronics / no sensors / zero data collection
✔ Safe for all anti‑doping regulations
✔ Approved as clothing in all Tier‑1 leagues
✔ No compression restrictions
✔ Non‑thermal / non‑powered infrared
✔ Proven safe in clinical studies
✔ Skin safe, no chemical treatments
✔ Match‑play safe in contact sports
"The squad have been very, very positive in their feedback using the kit"
Bob Stewart
Medical Lead - England Rugby