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Healthpal

FDA UDI

Class II (US FDA UDI)

by Xiamen Healthpal Electronic Co., Ltd

Identity

Trade Name
Healthpal FDA UDI
Generic Name
Hand-held deep-tissue electromagnetic stimulator FDA UDI
Model / Reference
FE-0161 FDA UDI

Identifiers

Primary DI / UDI-DI
06974000130002 FDA UDI
510(k) Number
K211850 FDA UDI
FDA Product Code
IRP FDA UDI
GMDN Term
Hand-held deep-tissue electromagnetic stimulator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5650 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Hand-held deep-tissue electromagnetic stimulator

Healthpal by Xiamen Healthpal Electronic Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held deep-tissue electromagnetic stimulator.

Cleared under the same submission

K211850 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xiamen Healthpal Electronic Co., Ltd

Sources (1)

  • FDA UDI 905e907b-458b-43ca-a89c-eea6aad57473 33 fields · synced May 30, 2026