Setmark Incorporated TR-135
by Setmark Inc.
Setmark Incorporated TR-135 is a handgrip disability-assistive walker (FDA Class I; FDA product code ITJ, Walker, Mechanical) made by Setmark Inc., listed in FDA GUDID since 31 Jan 2018 (UDI-DI 00854204008030), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00854204008030 | Date31 Jan 2018 | StatusListed |
Official records
- AccessGUDID record 00854204008030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Setmark Incorporated
- Generic name
- Handgrip disability-assistive walker, non-powered, foldable
- Model / reference
- TR-135
- Description
- Walker: adj height: 32"-36" Dark Blue
- Primary DI / UDI-DI
- 00854204008030
- FDA product code
- ITJ
- GMDN term
- Handgrip disability-assistive walker, non-powered, foldable
- Device class
- Class I
- Regulation number
- 890.3825
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
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Other devices filed under FDA product code ITJ (Walker, Mechanical).
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