From "medical equipment" to "consumer electronics"
In the high-end health product area of a high-end shopping mall in Shanghai, a silver "micro-pressure oxygen therapy chamber" is attracting the attention of passing customers. Unlike similar products three years ago, the words "adjuvant treatment" and "postoperative rehabilitation" are no longer seen in its promotional brochures. Instead, they are replaced by "family oxygen therapy center", "workplace energy supply station", "anti-fatigue light health care" and other expressions that are closer to daily life. The person in charge of the company to which this product belongs told reporters: "We adjusted the product positioning from 'Class II medical devices' to 'healthy home appliances', mainly to lower consumers' purchase thresholds and usage concerns."
Behind this phenomenon, an industry transformation about the "de-medicalization" of micro-pressure oxygen chambers is quietly unfolding. When the former "medical equipment" attempts to re-enter the mass market as "consumer electronics", the business logic and potential risks behind it are attracting multiple concerns from the medical community, regulators and consumers.
From "medical device" to "healthy home appliance": Behind the identity transformation
The core principle of the micro-pressure oxygen chamber is to increase the body's blood oxygen saturation and accelerate the discharge of metabolic waste through a combination of pressurization (1.3-1.5 times atmospheric pressure) and high-concentration oxygen (usually ≥90%). Because it was originally widely used in medical scenarios such as high altitude reaction first aid, carbon monoxide poisoning treatment, and postoperative wound repair, my country included it in the "Medical Device Classification Catalog" and classified it as a "Class II medical device" management-production requires a "Medical Device Production License", and the product must pass the strict registration inspection of the State Food and Drug Administration, and the propaganda must not exceed the medical scope of "auxiliary treatment" and "rehabilitation support".
However, since 2022, a number of micro-pressure oxygen chamber products claiming to be "home use" and "daily" have emerged on the market. They are labeled as "healthy home appliances" and "home oxygen therapy equipment" on e-commerce platforms, and the focus of publicity has shifted from "treating diseases" to "relieving fatigue", "enhancing energy" and "beauty and anti-aging"; offline experience halls have launched "light oxygen packages" at "99 yuan/time", and the target customer groups have expanded from "postoperative patients" and "highland tourists" to "white-collar workers in the workplace" and "sub-healthy people".
The marketing director of a head micro-compression oxygen chamber company revealed the motivation for the transformation to reporters: "The approval cycle of Class II medical devices is as long as 1-2 years, the production cost needs to increase by more than 30%, and the sales channels are limited (only medical institutions or designated pharmacies). After the conversion to "healthy home appliances", the production standards are implemented in accordance with small home appliances, the approval time is shortened to 3 months, and e-commerce platforms can sell directly, and the pricing is more flexible - the price of home use has dropped from 50,000-100,000 yuan in the past to 20,000-30,000 yuan, and sales have increased by 2 times."
The double-sided effect of "de-medicalization": lower thresholds or hidden risks?
For consumers, the most intuitive change brought about by "de-medicalization" is "easier to buy". Ms. Chen, an employee of an Internet company in Beijing, told reporters: "I heard that you had to go to the hospital to use the micro-pressure oxygen chamber before, but now there is an experience store in the mall downstairs. You can try it once for 200 yuan and buy it directly home." Data shows that in 2023, the sales of "home micro-pressure oxygen chambers" on Taobao and JD.com surged by 200% year-on-year, and "simple operation" and "no discomfort" became high-frequency words in user reviews.
However, the medical community remains cautious about this change. "The efficacy of the micro-pressure oxygen chamber is highly related to parameters such as pressure, oxygen concentration, and duration of use. The setting of these parameters must be based on strict clinical data." Zhang Liqun, member of the Standing Committee of the Hyperbaric Oxygen Medicine Branch of the Chinese Medical Association and director of the Hyperbaric Oxygen Department of Beijing Chaoyang Hospital, pointed out that "the pressure range of medical-grade micro-pressure oxygen chambers is usually 1.3-2.5ATA (atmospheric pressure), and the oxygen concentration is controlled at 93%±2%, and the plan needs to be adjusted according to the patient's age and condition. In order to reduce costs, some "consumer-grade" products have a pressure of only 1.1-1.2ATA, and the oxygen concentration fluctuates by ±5%, which may not achieve the expected effect and even cause discomfort such as dizziness and tinnitus."
What is more worthy of vigilance is the safety hazards caused by "information ambiguity". The reporter found in an undercover investigation that the details page of the "home micro-pressure oxygen chamber" on an e-commerce platform only marked "high-concentration oxygen" without specifying the specific value of the oxygen concentration; the sales staff of an offline experience center avoided the question of "whether it is suitable for patients with hypertension" and only emphasized that "everyone can use it." According to the "Safety Technical Specifications for Medical Micro-pressure Oxygen Chambers" (Draft for Comments), medical equipment must clearly mark "contraindicated groups" (such as uncontrolled hypertension, pregnant women, and patients with severe lung disease), but "consumer-grade" products currently do not have this requirement.
In November 2023, the "2023 Medical Device Quality and Safety Risk Investigation and Management Work Plan" issued by the State Food and Drug Administration specifically mentioned: "Some non-medical oxygen therapy equipment has problems such as substandard parameters and misleading publicity, and cross-departmental collaborative supervision needs to be strengthened." This indirectly confirms the regulatory blind spot behind "de-medicalization".
Industry Breakthrough: Standards First and Rational Cognition Are Indispensable
Faced with the controversy caused by "de-medicalization", the industry has begun to explore a path to break through. Some leading companies have taken the initiative to "return" to the medical track-although the "home micro-pressure oxygen chamber" launched by a technology company is positioned as a "healthy home appliance", it still applied for Class II medical device registration and marked "This product cannot replace drug treatment" in a prominent position in the product manual. The person in charge of the company explained: "We hope to build trust through compliant production and avoid damaging brand reputation due to opaque information."
At the regulatory level, the National Medical Products Administration issued the "Notice on Soliciting Opinions on the "Medical Micro-Compression Oxygen Chamber Registration Review Guidelines (Draft for Comments)" in December 2023, proposing to strictly include "micro-compression oxygen chambers with therapeutic functions" into the management of Class II medical devices, and at the same time clarify that non-medical equipment "only used for daily oxygen therapy" must comply with standards such as "Safety of Household and Similar Electrical Appliances". Industry experts suggest that the "medical-household" hierarchical management model can be used as a reference in the future: medical equipment is strictly approved by the Food and Drug Administration, and household equipment must be certified by a third-party testing agency, and clearly marked with "applicable scenarios", "contraindicated groups" and "usage tips".
For consumers, the convenience brought by "de-medicalization" needs to be balanced with rational cognition. "If it is mild fatigue or occasional insomnia, home micro-pressure oxygen chambers may be used as auxiliary means; but if it is long-term insomnia or cardiovascular and cerebrovascular disease patients, they must give priority to following clinical diagnosis and treatment plans." Professor Zhang Liqun emphasized, "Before purchasing, you should check whether the product has a third-party test report to confirm whether the core parameters such as oxygen concentration and pressure meet safety standards; before using, it is best to consult a doctor to assess whether you are suitable for oxygen therapy."
Conclusion: "De-medicalization" is not "de-responsibility"
From "medical equipment" to "consumer electronics", the transformation of micro-pressure oxygen chambers is essentially a collision between market demand and business logic. It lowers the threshold for use and allows more people to access oxygen therapy technology; but it also buries safety risks due to vague information and lack of standards.
As Li Yang, a researcher at the Department of Biomedical Engineering, School of Medicine, Tsinghua University, said: "The value of technology lies in serving people's health, not in creating concepts. The key to 'de-medicalization' is not the change in product labels, but whether the safety bottom line is maintained and whether scientific information is conveyed. Only when companies are self-disciplined, regulators follow up, and consumers are sober, can micro-pressure oxygen chambers truly change from 'marketing gimmicks' to 'health assistants'."
