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Newtowne Hyperbarics

FDA UDI

Class II (US FDA UDI)

by Typhoon Water Wares

Identity

Trade Name
Newtowne Hyperbarics FDA UDI
Generic Name
Hyperbaric chamber, portable FDA UDI
Device Name
Seal model, 38" diameter, portable hyperbaric chamber. FDA UDI
Model / Reference
Seal 38 FDA UDI
Description
Seal model, 38" diameter, portable hyperbaric chamber. FDA UDI

Identifiers

Primary DI / UDI-DI
00865439000256 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
Not 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 — 38 Inch FDA UDI
Length — 105 Inch FDA UDI

Newtowne Hyperbarics by Typhoon Water Wares — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K051759 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Typhoon Water Wares

Sources (1)

  • FDA UDI 414bfd48-542d-4753-9ca3-084d2f903cb7 38 fields · synced Jun 8, 2026