Massage Form® Shaper Attach

External Breast Prosthesis with Adhesive 11485 Massage Form® Shaper Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the soothing caress of ABC’s Massage Form® Shaper Attach.…

Registry build 21.09.26

External Breast Prosthesis with Adhesive 11485 Massage Form® Shaper Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the soothing caress of ABC’s Massage Form® Shaper Attach. Featuring our patented Massage Technology, this shaper cools as it massages to increase comfort, especially for women experiencing symptoms related to lymphedema. ABC’s integrated adhesive prevents shifting for secure comfort that lasts. This shaper conforms to your body’s curves creating a seamless transition and silhouette Size 10 Blush Color

2manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code KCZ
Manufacturer City Province Registered as Device types
Allmay Bodywear (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 21
Nanning Sixtant Biotechnology Co., Ltd. Nanning Guangxi Manufacturer 13

Record

Regulatory record for Massage Form® Shaper Attach
Listed by American Breast Care, L.P.
FDA product code KCZ
Device type Prosthesis, Breast, External, Used With Adhesive
Device class Class 1
Regulation 21 CFR 878.3800
Premarket notification Exempt
Record published 2020-05-15
Record revised 2021-07-22 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries serial number
Sizes Total volume 120 to 490 ml

Catalogue Numbers

Catalogue numbers for Massage Form® Shaper Attach
Catalogue number Size Status
11485-09-BH Total Volume 290 ml In distribution
11485-04-BH Total Volume 120 ml In distribution
11485-10-BH Total Volume 355 ml In distribution
11485-07-BH Total Volume 200 ml In distribution
11485-06-BH Total Volume 175 ml In distribution
11485-11-BH Total Volume 410 ml In distribution
11485-08-BH Total Volume 255 ml In distribution
11485-05-BH Total Volume 140 ml In distribution
11485-12-BH Total Volume 490 ml In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Amoena Amoena Medizin-Orthopädie-Technik GmbH 230
StecoTitanmagnetics® Steco-System-Technik Gmbh & Co. KG 55
my breast Natural Breast K.K. 37
Straumann Extraoral Implant System Institut Straumann AG 13
Massage Form® Attach American Breast Care, L.P. 12
ABC Nipple American Breast Care, L.P. 9

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