Identity
- Trade Name
- Guardian Supporter FDA UDI
- Generic Name
- Thoracic cage orthosis force meter FDA UDI
- Device Name
- "This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement." FDA UDI
- Model / Reference
- GKC-M FDA UDI
- Description
- "This product is a device that provides support by compressing or immobilizing certain parts of the body, such as the waist, knees, or neck. Including casting tape, but excluding those that do not provide support or reinforcement." FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809818038005 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 — 530 Millimeter FDA UDIWidth — 415 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bm Korea Co., Ltd
Sources (1)
- FDA UDI 322550fd-6a4a-48c5-b399-d5c633bd669d 34 fields · synced May 30, 2026