Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010182964

FEI Number

3010182964

Entity Name

CHANGZHOU BOER PLASTIC

City/State/Country

Changzhou City Jiangsu, CN

Establishment Address

No.65 Longyi Road, Wujin High Tech Development Zone, Changzhou City Jiangsu 213164, CN

Establishment Type(s)

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

Owner / Operator

Changzhou Boer Plastic (Owner Number: 10042497)

Owner / Operator Contact Address

No. 3, Longwo Road, Wujin High Tech Development Zone, Changzho City, CN-JS 213164, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GREEN 65CM EXERCISE BALL (23030) GREEN 65CM BULK EXERCISE BALL (23130) PRO SERIES GRN 65CM RETAIL (23035) PRO SERIES YEL 45CM BULK BALL (23115) PRO SERIES SIL 85CM BULK BALL (23155) BLUE 75CM EXERCISE BALL (23040) PRO SERIES BLU 75CM BULK BALL (23145) SILVER 85CM BULK X-BALL (23150) YELLOW 45CM EXERCISE BALL (23010) YELLOW 45CM BULK EXERCISE (23110) PRO SERIES RED 55CM RETAIL (23025) RED 55CM EXERCISE BALL (23020) PRO SERIES GRN 65CM BULK BALL (23135) BLUE 75CM BULK EXERCISE BALL (23140) PRO SERIES RED 55CM BULK BALL (23125) PRO SERIES YEL 45CM RETAIL (23015) RED 55CM BULK EXERCISE BALL (23120) PRO SERIES BLU 75CM RETAIL BALL (23045)

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	2012-12-03

Official Correspondent

Ariel Zhu

US Agent Details

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

Related Public Records

Same Entity

Changzhou Boer Plastic

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 3010182964. Last updated year: 2026. Please use registration number 3010182964 when referencing this establishment in official correspondence.