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Winback Back 3SE

FDA UDI

Class II (US FDA UDI)

by Daeyang Medical Co., Ltd.

Identity

Trade Name
Winback Back 3SE FDA UDI
Generic Name
Multi-modality physical therapy system, professional-use FDA UDI
Model / Reference
1085 FDA UDI

Identifiers

Primary DI / UDI-DI
08800092010855 FDA UDI
510(k) Number
K162828 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

Winback Back 3SE 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Daeyang Medical Co., Ltd.

Sources (1)

  • FDA UDI 1b877339-8348-4ce4-951a-29a243948ba8 34 fields · synced May 30, 2026