Identity
- Trade Name
- Newtowne Hyperbarics FDA UDI
- Generic Name
- Hyperbaric chamber, portable FDA UDI
- Device Name
- Seal 34" mild hyperbaric chamber FDA UDI
- Model / Reference
- S34 V2.0 FDA UDI
- Description
- Seal 34" mild hyperbaric chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852834007041 FDA UDI
- 510(k) Number
- K051759 FDA UDI
- FDA Product Code
- CBF FDA UDI
- GMDN Term
- Hyperbaric chamber, portable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5470 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
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 34 Inch FDA UDILength — 95 Inch FDA UDI
Category: Hyperbaric chamber, portable
Newtowne Hyperbarics by Typhoon Water Wares — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K051759 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
- Typhoon Water Wares
Sources (1)
- FDA UDI 04fabd89-32ff-4bed-8f95-d4c023608c98 37 fields · synced Jun 1, 2026