← Back to catalogue

Back 3 COLOR

FDA UDI

Class II (US FDA UDI)

by Daeyang Medical Co., Ltd.

Identity

Trade Name
Back 3 COLOR FDA UDI
Generic Name
Multi-modality physical therapy system, professional-use FDA UDI
Model / Reference
2003 FDA UDI

Identifiers

Primary DI / UDI-DI
08800092020038 FDA UDI
510(k) Number
K214090 FDA UDI
FDA Product Code
PBX FDA UDI
GMDN Term
Multi-modality physical therapy system, professional-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4400 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multi-modality physical therapy system, professional-use

Back 3 COLOR by Daeyang Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality physical therapy system, professional-use.

Cleared under the same submission

K214090 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Daeyang Medical Co., Ltd.

Sources (1)

  • FDA UDI 6a4c1252-c68a-4d56-8dba-8f76c5f67630 34 fields · synced Jun 8, 2026