ShotBlocker

ShotBlocker® 2000 ct. Retail

Registry build 21.09.26
113manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (49), Zhejiang (27), Jiangsu (9). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code LYG
Manufacturer City Province Registered as Device types
Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd Foshan Guangdong Contract manufacturer 11
Xiamen Solex High-Tech Industries Co., Ltd. Xiamen Fujian Contract manufacturer 9
Inspiration MFG. & Trading Co. Dongguan Guangdong Contract manufacturer 8
Dongguan Esino Manufacturing Service Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Guangzhou Lead Fair Plastic Co., Ltd. Guangzhou Guangdong Contract manufacturer 3
GW Sporting Goods Co., Ltd. Nantong Jiangsu Contract manufacturer 3
JIN HUA City Xing BU Technology Co., Ltd. Jinhua Zhejiang Contract manufacturer 3
Cixi Yongye Furniture Co., Ltd. Cixi Zhejiang Contract manufacturer 2
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Ningbo Ningyuan Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 80
Shandong Zhushi Pharmaceutical Group Co., Ltd. Heze Shandong Contract manufacturer 65
AID United International Co., Limited Shanghai Shanghai Specification developer 65

Showing 12 of 113. All 113 manufacturers in China registered for Massager, Therapeutic, Manual

Record

Regulatory record for ShotBlocker
Listed by Bionix, LLC, United States
FDA product code LYG
Device type Massager, Therapeutic, Manual
Device class Class 1
Regulation 21 CFR 890.5660
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2024-03-15
Record revised 2023-10-06 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2025-08-06
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for ShotBlocker
Catalogue number Size Per pack Status
SB-08004 1,000 In distribution
8050 50 In distribution
08002 5 In distribution
8100 100 In distribution
08001 Withdrawn
SB-8003 2,000 Withdrawn
801-SD 12 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Waterpik PowerPulse Water PIK, Inc. 74
Artsun Dongguan Dengrong Arts & Crafts Co., Ltd. 23
B-Pure Fourstar Group 14
Waterpik RainFall+ with PowerPulse Water PIK, Inc. 12
Lucky Dragon Lucky Dragon Enterprise Group Inc. 10
Bios Living Thermor Ltd. 7
Waterpik PowerPulse with DualDock Water PIK, Inc. 6
Waterpik HairWand with PowerPulse Spa System Water PIK, Inc. 4
Nice ICE Surgical Products Corp. 4
Waterpik ShowerClean Pro with PowerPulse and PowerJET Water PIK, Inc. 4
Waterpik PowerPulse 2in1 Shower System with One Touch Water PIK, Inc. 3
WaterPik Transform RV with PowerPulse Water PIK, Inc. 3

Showing 12 of 80. All products under Massager, Therapeutic, Manual

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer