Identity
- Trade Name
- RESPeRATE FDA UDI
- Generic Name
- Biofeedback system FDA UDI
- Device Name
- RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pressure. RESPeRATE does so by harnessing the therapeutic power of slow-paced breathing with prolonged exhalation in a way that is virtually impossible to achieve on your own. All you have to do is breathe along with RESPeRATE’s guiding tones. FDA UDI
- Model / Reference
- Deluxe FDA UDI
- Description
- RESPeRATE lowers blood pressure by relaxing constricted blood vessels which cause high blood pressure. RESPeRATE does so by harnessing the therapeutic power of slow-paced breathing with prolonged exhalation in a way that is virtually impossible to achieve on your own. All you have to do is breathe along with RESPeRATE’s guiding tones. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290017402017 FDA UDI
- 510(k) Number
- K020399 FDA UDI
- FDA Product Code
- HCC FDA UDI
- GMDN Term
- Biofeedback system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biofeedback system
RESPeRATE by 2breathe Technologies Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020399 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- 2breathe Technologies Ltd
Sources (1)
- FDA UDI 7f9aaee3-6906-4028-ad76-6821678034ee 34 fields · synced May 30, 2026