Identity
- Trade Name
- Guardian Supporter FDA UDI
- Generic Name
- Thoracic cage orthosis force meter FDA UDI
- Device Name
- This product is a device designed to provide support by compressing and immobilizing certain parts of the body (such as the waist, knees, wrists, or back); products that do not offer support or stabilization are excluded. FDA UDI
- Model / Reference
- GAK-S FDA UDI
- Description
- This product is a device designed to provide support by compressing and immobilizing certain parts of the body (such as the waist, knees, wrists, or back); products that do not offer support or stabilization are excluded. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809818038074 FDA UDI
- FDA Product Code
- MNE FDA UDI
- GMDN Term
- Thoracic cage orthosis force meter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3475 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 155 Millimeter FDA UDIWidth — 250 Millimeter FDA UDI
Category: Thoracic cage orthosis force meter
Guardian Supporter by Bm Korea Co., Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic cage orthosis force meter.
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
- Guardian Supporter — BM KOREA CO., LTD · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Bm Korea Co., Ltd
Sources (1)
- FDA UDI 170c9f0e-0b31-4ad1-8597-d30574717eda 34 fields · synced May 30, 2026