Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010168049

FEI Number

3010168049

Entity Name

SHEN KANG ENTERPRISE CO., LTD.

City/State/Country

Hsin-Chuang Taipei, TW

Establishment Address

No. 2, Lane 101, Chyonglin S. Rd., Hsin-Chuang Taipei 242, TW

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shen Kang Enterprise Co., Ltd. (Owner Number: 10042383)

Owner / Operator Contact Address

No. 2, Lane 101, Chyonglin S. Rd., Hsin-Chuang, TW-TPE 242, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Thera-Band 13" Silver Stability Disc (23303) Thera-Band 9" Yellow Soft Mini Ball (23085)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2012-11-21

Official Correspondent

Vicky Wang

US Agent Details

Melanie Leibowitz Email: melanie.leibowitz@performancehealth.com Phone: (331) 6889688

Related Public Records

Same Entity

Shen Kang Enterprise Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010168049. Last updated year: 2026. Please use registration number 3010168049 when referencing this establishment in official correspondence.