Identity
- Trade Name
- Hyperbaric for Life FDA UDI
- Generic Name
- Hyperbaric chamber, stationary FDA UDI
- Device Name
- Hyperbaric Chamber FDA UDI
- Model / Reference
- 8003 FDA UDI
- Description
- Hyperbaric Chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- G625R800340 FDA UDI
- 510(k) Number
- K041007 FDA UDI
- FDA Product Code
- CBF FDA UDI
- GMDN Term
- Hyperbaric chamber, stationary 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hyperbaric chamber, stationary
Hyperbaric for Life by Hyperbaric For Life.com, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hyperbaric chamber, stationary.
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
- Perry Sigma Monoplace — Perry Baromedical Corporation · Class II
- Sechrist Industries, Inc. — Sechrist Industries Inc · Class II
Cleared under the same submission
K041007 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hyperbaric For Life.com, Llc
Sources (1)
- FDA UDI 615bd2f0-00c9-4f60-ba35-3147214542cf 34 fields · synced May 30, 2026