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ComfyHealth

FDA UDI

Class I (US FDA UDI)

by Comfy Health Group Co., Ltd.

Identity

Trade Name
ComfyHealth FDA UDI
Generic Name
Multiple-joint lower limb orthosis FDA UDI
Device Name
BRACOO KP31 Knee Fulcrum Wrap Sponged Ergo Stabilizer FDA UDI
Model / Reference
KP31 FDA UDI
Description
BRACOO KP31 Knee Fulcrum Wrap Sponged Ergo Stabilizer FDA UDI

Identifiers

Primary DI / UDI-DI
04719879640007 FDA UDI
FDA Product Code
IQI FDA UDI
ITQ FDA UDI
GMDN Term
Multiple-joint lower limb orthosis 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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple-joint lower limb orthosis

ComfyHealth by Comfy Health Group Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-joint lower limb orthosis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Comfy Health Group Co., Ltd.

Sources (1)

  • FDA UDI 50411dea-2ea7-4136-9bad-156e2a51c4a5 33 fields · synced Jun 8, 2026