Massage Form® Attach

External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the cooling comfort and secure wear of the Massage Form ®…

Registry build 21.09.26

External Breast Prosthesis with Adhesive 10475 Massage Form® Attach Patented Massage Technology- Massages, Hugs, Cools Enjoy the cooling comfort and secure wear of the Massage Form ® Attach. ABC’s integrated adhesive keeps this lightweight form securely in place for a natural look and comfortable fit. Featuring ABC’s Patented Massage Technology, specialized channels encourage airflow, helping to reduce heat retention and provide a soothing touch. This prosthesis is especially great for women experiencing symptoms associated with Lymphedema. Size 11 Blush Color

2manufacturers in China registered for this device type
12catalogue 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® 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 115 to 1120 ml

Catalogue Numbers

Catalogue numbers for Massage Form® Attach
Catalogue number Size Status
10475-04-BH Total Volume 265 ml In distribution
10475-08-BH Total Volume 595 ml In distribution
10475-02-BH Total Volume 160 ml In distribution
10475-11-BH Total Volume 945 ml In distribution
10475-06-BH Total Volume 410 ml In distribution
10475-09-BH Total Volume 695 ml In distribution
10475-07-BH Total Volume 515 ml In distribution
10475-01-BH Total Volume 115 ml In distribution
10475-12-BH Total Volume 1120 ml In distribution
10475-05-BH Total Volume 330 ml In distribution
10475-10-BH Total Volume 815 ml In distribution
10475-03-BH Total Volume 205 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
ABC Nipple American Breast Care, L.P. 9
Massage Form® Shaper Attach 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