# TREXO ROBOTICS HOLDINGS · 89-08 · CANADA — FDA import alert red lists: firms subject to detention without physical examination

For TREXO ROBOTICS HOLDINGS · 89-08 · CANADA, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CANADA; product is Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Plus | Trexo Home | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home; product code is 87 H - - TQ Broach | 87 H - - TQ Broach | 87 O - - JP orthopedic computer controlled surgical system | 87 O - - JP orthopedic computer controlled surgical system | 89 I - - KK System, Isokinetic Testing And Evaluation | 89 I - - KK System, Isokinetic Testing And Evaluation | 89 I - - TI Wheelchair, Powered | 89 I - - TI Wheelchair, Powered | 89 I - - TJ Walker, Mechanical | 89 I - - TJ Walker, Mechanical | 89 K - - NO Accessories, Wheelchair | 89 K - - NO Accessories, Wheelchair | 89 K - - NP Orthosis, Corrective Shoe | 89 K - - NP Orthosis, Corrective Shoe; date published is 07/05/2024; address is 5700 Timberlea Blvd , Unit 9-10 , Mississauga, Ontario CANADA, verified against its source on 2026-09-16.

- **Firm:** TREXO ROBOTICS HOLDINGS _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CANADA _(verified: appears in the quote below)_
- **Address:** 5700 Timberlea Blvd , Unit 9-10 , Mississauga, Ontario CANADA _(verified: appears in the quote below)_
- **Date published:** 07/05/2024 _(verified: appears in the quote below)_
- **Product code:** 87 H - - TQ Broach | 87 H - - TQ Broach | 87 O - - JP orthopedic computer controlled surgical system | 87 O - - JP orthopedic computer controlled surgical system | 89 I - - KK System, Isokinetic Testing And Evaluation | 89 I - - KK System, Isokinetic Testing And Evaluation | 89 I - - TI Wheelchair, Powered | 89 I - - TI Wheelchair, Powered | 89 I - - TJ Walker, Mechanical | 89 I - - TJ Walker, Mechanical | 89 K - - NO Accessories, Wheelchair | 89 K - - NO Accessories, Wheelchair | 89 K - - NP Orthosis, Corrective Shoe | 89 K - - NP Orthosis, Corrective Shoe _(verified: each item appears in the quote below)_
- **Product:** Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Plus | Trexo Home | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home _(verified: each item appears in the quote below)_
- **FDA notes:** DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill | DWPE applies to medical device accessories and treadmill _(verified: each item appears in the quote below)_

## What the source says

> TREXO ROBOTICS HOLDINGS Date Published : 07/05/2024 5700 Timberlea Blvd , Unit 9-10 , Mississauga, Ontario CANADA 87 H - - TQ Broach Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill 87 H - - TQ Broach Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 87 O - - JP orthopedic computer controlled surgical system Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill 87 O - - JP orthopedic computer controlled surgical system Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 89 I - - KK System, Isokinetic Testing And Evaluation Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 89 I - - KK System, Isokinetic Testing And Evaluation Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill 89 I - - TI Wheelchair, Powered Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill 89 I - - TI Wheelchair, Powered Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 89 I - - TJ Walker, Mechanical Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill 89 I - - TJ Walker, Mechanical Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 89 K - - NO Accessories, Wheelchair Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 89 K - - NO Accessories, Wheelchair Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill 89 K - - NP Orthosis, Corrective Shoe Date Published: 07/05/2024 Desc: Trexo Plus Notes: DWPE applies to medical device accessories and treadmill 89 K - - NP Orthosis, Corrective Shoe Date Published: 07/05/2024 Desc: Trexo Home Notes: DWPE applies to medical device accessories and treadmill

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).