AccessGUDID - DEVICE: Healthpal (06974000130026)

GUDID

Device Identifier (DI) Information

Brand Name: Healthpal
Version or Model: FE-7513
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Xiamen Healthpal Electronic Co., Ltd.

Primary DI Number: 06974000130026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 553874367 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60310	Body infrared reflective phototherapy skin patch	A skin patch intended to reflect naturally emitted infrared energy back into the body, with a reduced range of wavelength (phototherapeutic stimulation of the skin), to assist one or more of the following therapeutic outcomes: wound healing, pain relief, improved energy, improved sleep, reduced cravings, and general wellbeing. It can be applied as a single, double or multiple patch(es). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRP	Massager, Powered Inflatable Tube

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K211850	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db68d54d-8b15-4ce1-8c93-241132dd53f9
Public Version Date: January 10, 2025
Public Version Number: 1
DI Record Publish Date: January 02, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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