Equinox Relieve
Equinox Relieve supplies a fixed equal mixture of nitrous oxide and oxygen for a conscious patient who is breathing spontaneously. It is a portable, pneumatically powered analgesic…
Equinox Relieve supplies a fixed equal mixture of nitrous oxide and oxygen for a conscious patient who is breathing spontaneously. It is a portable, pneumatically powered analgesic gas-mixing and delivery system.
Two regulated gas-cylinder connections supply the mixer. With the unit switched on, the patient’s inhalation activates delivery; the mixture ratio is preset and cannot be adjusted by the patient or operator.
Listed Item
The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. It provides two input connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has only one control for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N2O/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.
Delivery and Alarms
The system is used with a patient circuit and face mask. Audible and visual alarms indicate low gas-input pressure, and the unit shuts off if either supply falls below the specified threshold. A secondary circuit also stops operation for specified internal mixer or hose faults. Applications include prehospital and hospital pain-relief settings.
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Gentec (Shanghai) Corporation | Shanghai | Shanghai | Manufacturer | 12 |
Record
| Listed by | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K113687 |
| Record published | 2018-10-25 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 60 °C |
| Sizes | Weight 1.5 kg; height 3.9 in; width 6.6 in; length 8.9 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01EQ1000 | Weight 1.5 kg | In distribution |
| 01EQ1000F | Length 8.9 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 43 |
| Hyperinflation | Westmed, Inc. | 21 |
| Blender | Carefusion | 19 |
| Hyperinflation (Ambu) | Westmed, Inc. | 19 |
| MAXBLEND2 | Maxtec, LLC | 17 |
| Blender | Vyaire Medical, Inc. | 17 |
| Ambu Hyperinflation System | Westmed, Inc. | 12 |
| Ambu | SunMed Group Holdings, LLC | 12 |
| MaxFlo2 | Maxtec, LLC | 11 |
| MicroMax | Maxtec, LLC | 9 |
| Bird™ | Vyaire Medical, Inc. | 8 |
| Gentec® | Gentec (Shanghai) Corporation | 8 |
Showing 12 of 118. All products under Mixer, Breathing Gases, Anesthesia Inhalation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173205 | 2018-08-29 |
| K113687 | 2012-04-30 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Carestream Health, Inc. | 510(k) number | 2018-05-15 | Class II | Under Investigation by firm | Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing. | 919 Units Total | 2025-12-17 |
| O-TWO Medical Technologies, Inc. | 510(k) number | 2018-05-14 | Class II | Device Design | Higher levels of nitrous oxide delivered than specification | 3 units | 2020-06-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.