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Imak Rsi
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref A30141 Model UniversalRef A10112Model AdjustableRef A30140Ref A10110Model X-LargeRef A20162Model MediumRef A10113Model Universal Ref 60010Model Medium - 6.5"-7.5" Ref A20163Model Large
Identity
- Trade Name
- Arm Sling Immobilizer EUDAMEDIMAK® RSI EUDAMEDIMAK RSI FDA UDI
- Generic Name
- Suspension arm sling FDA UDIWrist orthosis FDA UDICompression/pressure glove FDA UDIElbow joint orthosis component FDA UDI
- Device Name
- IMAK® RSI Arm Sling Immobilizer EUDAMEDIMAK® RSI Pil-O-Splint EUDAMEDIMAK® RSI Arm Sling EUDAMEDIMAK® RSI Elbow Support EUDAMEDIMAK® RSI Smart Glove EUDAMEDIMAK® RSI WRISTIMER® EUDAMEDArm Sling with Immobilizer FDA UDIPil-O-Splint FDA UDISmart Glove w/Thumb FDA UDIElbow Support FDA UDIWRISTIMER® FDA UDI
- Model / Reference
- A30141 EUDAMEDFDA UDIA10112 EUDAMEDFDA UDIA20163 EUDAMEDFDA UDIA10113 EUDAMEDFDA UDI60010 EUDAMEDFDA UDIA20162 EUDAMEDFDA UDIUniversal EUDAMEDAdjustable EUDAMEDA30140 EUDAMEDX-Large EUDAMEDA10110 EUDAMEDMedium EUDAMEDMedium - 6.5"-7.5" EUDAMEDLarge EUDAMED
- Description
- Arm Sling with Immobilizer FDA UDIPil-O-Splint FDA UDISmart Glove w/Thumb FDA UDIElbow Support FDA UDIWRISTIMER® FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00649833301412 EUDAMEDFDA UDI00649833201637 EUDAMEDFDA UDI00649833201620 EUDAMEDFDA UDI06498331011286 EUDAMED06498333014124 EUDAMED06498331011040 EUDAMED06498331011354 EUDAMED00821616001072 EUDAMED00649833101128 FDA UDI00649833101135 FDA UDI00082161600107 FDA UDI
- Basic UDI-DI
- 649833IMAKRASIKX EUDAMED649833IMAKRPOSADJ83 EUDAMED649833IMAKRASFH EUDAMED649833IMAKRESXLXU EUDAMED649833IMAKRSGWTMDAU EUDAMED649833IMAKRESFV EUDAMED082161IMAKRWTMDEZ EUDAMED649833IMAKRSGWTLGAX EUDAMED
- FDA Product Code
- ILI FDA UDIILH FDA UDIIOY FDA UDIIRA FDA UDI
- EMDN Code
- M030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE EUDAMEDM03050299 BANDAGES AND SPLINTS - OTHER EUDAMEDM0304010101 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, LOW EXTENSIBILITY (<70%) EUDAMED
- GMDN Term
- Suspension arm sling FDA UDIWrist orthosis FDA UDICompression/pressure glove FDA UDIElbow joint orthosis component FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.3640 FDA UDI890.3475 FDA UDI890.3420 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Suspension arm sling
Imak Rsi by Brownmed, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Suspension arm sling.
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- Redicare — REDICARE LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brownmed, Inc.
Sources (14)
- FDA UDI 408576f7-45ef-4db0-8d65-4acec017a296 33 fields · synced Sep 17, 2026
- FDA UDI 35af62f9-c9ea-425c-bedd-c0f152a9d76d 33 fields · synced May 27, 2026
- FDA UDI 5543fc6f-0ad2-4e0e-b205-8d119d61ef8a 33 fields · synced May 29, 2026
- FDA UDI 818d8e73-1ab5-4ccc-b2a3-c14603be19da 33 fields · synced May 30, 2026
- FDA UDI 30f6e115-320d-4943-8e5d-eb4ba54ebf23 33 fields · synced May 30, 2026
- FDA UDI a0419ad6-cf0c-4498-bae1-11ee0b1fd57e 33 fields · synced May 30, 2026
- EUDAMED d622160f-4d99-4699-94d7-4678b0c83725 61 fields · synced Jun 18, 2026
- EUDAMED 4c01e7ca-5341-4ede-af12-f8dbfac52b44 61 fields · synced Jul 10, 2026
- EUDAMED 59b22cd5-25d5-4cd5-953f-bae472704b6e 61 fields · synced Jul 10, 2026
- EUDAMED 5c2ec61f-b87b-47b7-a638-1f233e15e1cd 61 fields · synced Jul 11, 2026
- EUDAMED 845cfd03-0f95-434d-b5b4-9b4c8aa9b525 61 fields · synced Jul 15, 2026
- EUDAMED a43d5066-3e1a-4bf3-8b03-de16cffebc01 61 fields · synced Jul 18, 2026
- EUDAMED 68788c9c-eb5a-4c49-8a4e-01361b008c51 61 fields · synced Jul 19, 2026
- EUDAMED c82e02b5-9daf-4025-9df1-babf77034de7 61 fields · synced Sep 17, 2026