Identity
- Trade Name
- Quamvis Lite 320 FDA UDI
- Generic Name
- Hyperbaric chamber, portable FDA UDI
- Device Name
- Hyperbaric Chamber FDA UDI
- Model / Reference
- 15C38154 FDA UDI
- Description
- Hyperbaric Chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10856039006714 FDA UDI
- 510(k) Number
- K001409 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 32 Inch FDA UDI
Category: Hyperbaric chamber, portable
Quamvis Lite 320 by Hyperbaric Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hyperbaric chamber, portable.
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- Newtowne Hyperbarics — TYPHOON WATER WARES · Class II
- Newtowne Hyperbarics — TYPHOON WATER WARES · Class II
- Newtowne Tent Chamber — TYPHOON WATER WARES · Class II
- Summit to Sea — Summit to Sea, LLC. · Class II
- Newtowne Hyperbarics — TYPHOON WATER WARES · Class II
Cleared under the same submission
K001409 also covers:
- Gamow Bag — HYPERBARIC TECHNOLOGIES, INC.
- Gamow Ultra-Lite — HYPERBARIC TECHNOLOGIES, INC.
- Quamvis 270 — HYPERBARIC TECHNOLOGIES, INC.
- Quamvis 320 — HYPERBARIC TECHNOLOGIES, INC.
- Respiro 270 — HYPERBARIC TECHNOLOGIES, INC.
- Solace 210 — HYPERBARIC TECHNOLOGIES, INC.
- Vitaeris 320 — HYPERBARIC TECHNOLOGIES, INC.
- Vitaeris 320 — HYPERBARIC TECHNOLOGIES, INC.
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
- Hyperbaric Technologies, Inc.
Sources (1)
- FDA UDI be80c3d7-bbee-4757-b880-7dfe53cf84f5 36 fields · synced Jun 7, 2026