ORRA / Compliance
Eight standards, none of them cleared.
This is the wall between a working prototype and something that can legally be sold. It is a fixed cost, it does not scale down with volume, and it is the part of a hardware programme that most concepts never reach.
| Standard | Covers | Why this product needs it |
|---|---|---|
| IEC 60601-1 | Electrical safety | Basic safety for equipment in contact with skin. Verifies the hard cut-off that stops the Peltier before it can burn. |
| IEC 62471 | Photobiological safety | Confirms the 660 nm and 810 nm array is safe for skin and incidental eye exposure. |
| ISO 10993 | Biocompatibility | Lab proof that the silicone and the fabrics do not irritate skin over long wear. |
| FCC Part 15 | Radio (US) | Required for the Bluetooth radio. No FCC ID, no US sale. |
| CE / RED | Radio (EU) | The European equivalent, plus the CE mark for the EU market. |
| UN 38.3 | Battery transport | Vibration, shock and thermal tests. Without it the lithium cell cannot legally fly. |
| UL 2054 / IEC 62133 | Battery safety | Cell behaviour under drop, overcharge and short. |
| RoHS / REACH | Materials | No restricted substances in the assembly. |
Status on all eight: not started. No test house has been engaged, no pre-scan has been run and no file has been opened. Any material that shows a certification logo against an ORRA product is wrong.
The fork
Wellness or medical, and why it matters more than it sounds
The same hardware can be two entirely different regulatory products depending on what is said about it.
Marketed for focus, readiness, recovery routine and sleep routine, and without claims about a disease, it sits under the FDA's General Wellness policy. That path is open now and it does not require clearance.
Marketed as treating a condition, of any kind, it becomes a regulated medical device requiring clearance, with clinical evidence, a quality system and a timeline measured in years and a budget measured in millions.
ORRA is on the wellness path. That is a deliberate constraint on what this company is allowed to say, and it is the reason the copy on this site is narrower than the copy in the concept material it came from.
The list
What we do not claim
Written down so it can be checked, and so nobody drafting a deck later has to guess.
- ORRA does not treat, cure, diagnose or prevent any disease or condition.
- ORRA does not treat repetitive strain injury, carpal tunnel syndrome, plantar fasciitis, chronic fatigue, depression, anxiety or attention disorders. The source concept material used some of that language. It is not used here.
- ORRA does not shield you from 5G, WiFi or any other environmental radio source. That is not physically achievable from a worn device, and the reasoning is on the Node page.
- ORRA does not reduce inflammation, accelerate healing, or make any other physiological claim that would require clinical evidence.
- ORRA has no clinical data. No study has been run, no human has used a unit, and no unit exists.
- No ORRA frequency has been derived from a protein simulation. That method is the plan, described on the science page. It is not a result.
- No ORRA patent has been filed. Claims have been drafted; nothing is pending at the USPTO, and the word "patent pending" does not apply to any ORRA product today.
Ready to look at the engineering?
The layer stack, the component list with manufacturer part numbers and the mode table are written down. Ask and you get the same document a contract manufacturer would.
See what it would cost
Concept retail against a real bill of materials, with the margin shown rather than implied.
Pricing →Start with the science
Three physical layers, six set points, one calibration baseline. Ninety seconds of reading.
How it works →