FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Brace Direct
DI: 00686162751389
·
Model: CTY159-2
·
BRACE ALIGN LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Brace Direct
- Primary DI
- 00686162751389
- Version / Model
- CTY159-2
- Company Name
- BRACE ALIGN LLC
- Labeler DUNS
- 108094498
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-19
- Public Version
- 3
- Public Version Date
- 2025-12-01
- Public Version Status
- Update
- Public Device Record Key
- 58b3f4bf-6e6a-49fd-9ac2-0553104b3a63
- Distribution End Date
- 2025-11-30
Device Description
Experience targeted relief from joint pain, post-workout fatigue, and post-surgery inflammation with the Brace Direct Frozen Heat Therapy Unit. Portable, versatile, and designed for both cold and hot treatments to speed up recovery.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ILO | Pack, Hot Or Cold, Water Circulating | Physical Medicine | 890.5720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62442 | Circulating-fluid localized thermal therapy system | An assembly of devices intended to be used to pump heated and/or cooled fluid (e.g., water) through externally applied packs for localized hot and/or cold therapy to help treat a variety of adverse conditions resulting from musculoskeletal injury (e.g., pain, swelling, inflammation). It includes one or more hot and/or cold therapy packs (e.g., anatomically specific wraps), and a mains electricity (AC-powered) fluid pump and heating/cooling unit with controls/display; the device is not intended for wrap inflation. It is intended for use in both professional and home settings. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00686162751389 | GS1 |