Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014948462

FEI Number

3014948462

Entity Name

HARVEST SPF TEXTILE(BEIJING)CO.,LTD

City/State/Country

Beijing, CN

Establishment Address

1902,16th Floor,8 Building,88 Jianguolu Road,Chaoyang District, Beijing 100022, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Harvest SPF Textile(Beijing)Co.,Ltd (Owner Number: 10062268)

Owner / Operator Contact Address

1902,16th Floor,8 Building,88 Jianguolu Road,Chaoyang District, Beijing, CN-BJ 100022, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Compression elbow sleeve Compression knee sleeve Sauna blanket Compression full leg sleeve,Compression calf sleeve Compression foot sleeve,Compression wrist sleeve,Compression ankle sleeve,Compression short sleeve shirt Compression long sleeve shirt,Compression short pants,Compression long pants Thigh sleeve,long arthritis gloves Compression Half Finger Gloves,Compression Full Finger Gloves Compression back brace Compression socks Massage Gloves, Vibrating arthritis gloves Heated Vibrating knee sleeve, Heated Vibrating gloves, Heated Vibrating back brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2020-01-06
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2020-01-06
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2022-09-19
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2020-01-06
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2020-01-06
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2020-01-06
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2020-01-06
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2020-01-06
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2021-01-03

Official Correspondent

Xinyuan Xu

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Harvest SPF Textile(Beijing)Co.,Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014948462. Last updated year: 2026. Please use registration number 3014948462 when referencing this establishment in official correspondence.