Procare
Deluxe ARM Sling (XL), Health Care EXP
126manufacturers in China registered for this device type
10catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Zhejiang (31), Jiangsu (28), Guangdong (23). 21 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Leison Medical & Healthcare Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 32 |
| Planet (Anhui) Medical Products Co., Ltd. | Chuzhou | Anhui | Contract manufacturer | 30 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Dongguan NAN YOU Sporting Goods Enterprise Ltd | Dongguan | Guangdong | Contract manufacturer | 23 |
| Fortune Company Ltd. | Huizhou | Guangdong | Contract manufacturer | 23 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Allmay Bodywear (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 21 |
| Xiantao Rayxin Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 18 |
| Guangdong Hexin Technology Weaving Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 17 |
Showing 12 of 126. All 126 manufacturers in China registered for Sling, Arm
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | ILI |
| Device type | Sling, Arm |
| Device class | Class 1 |
| Regulation | 21 CFR 890.3640 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 79-84007-0213 | In distribution | |
| 155-79-84023 | In distribution | |
| 79-84003-0213 | In distribution | |
| 79-84005-0213 | In distribution | |
| 155-79-84300 | In distribution | |
| 79-84008-0213 | In distribution | |
| 155-79-84028 | In distribution | |
| 155-79-84027 | In distribution | |
| 155-79-84022 | In distribution | |
| 155-79-84025 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 444 |
| Wellbrace | Pantymed S.A. | 22 |
| Sling, Arm | Tetra Medical Supply Corp. | 19 |
| Padded Arm Sling | Medical Specialties, Inc. | 16 |
| Joslin | Brownmed | 13 |
| E.M Adams Co., Inc. | E.M. Adams Co., Inc. | 10 |
| ManaMed | Manamed LLC | 9 |
| Medco Sports Medicine | ASP Global, LLC | 8 |
| Sling, Arm | Zimmer Orthopaedic Surgical Products | 7 |
| Shoulder Immobilizer | Medical Specialties, Inc. | 7 |
| Vector Abducted Shoulder Immobilizer | Medical Specialties, Inc. | 6 |
| Arm Sling | Dynarex Corp. | 6 |
Showing 12 of 136. All products under Sling, Arm
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2021-04-12 | Class II | Under Investigation by firm | failed rivet at the chafe tab of arm sling. | 2024-03-21 |
| 2021-04-12 | Class II | Under Investigation by firm | failed rivet at the chafe tab of arm sling. | 2024-03-21 |
| 2021-04-12 | Class II | Under Investigation by firm | failed rivet at the chafe tab of arm sling. | 2024-03-21 |
| 2021-04-12 | Class II | Under Investigation by firm | failed rivet at the chafe tab of arm sling. | 2024-03-21 |
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.