TREXO ROBOTICS HOLDINGS · 89-08 · CANADA
For TREXO ROBOTICS HOLDINGS, import alert is 89-08; country is CANADA; 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)"; product is Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus; 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 2026-09-30.
- Firm
- TREXO ROBOTICS HOLDINGS verified
- 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
- Address
- 5700 Timberlea Blvd , Unit 9-10 , Mississauga, Ontario CANADA verified
- Date published
- 07/05/2024 verified
- 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 each item verified
- Product
- Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus each item verified
- 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 each item verified
What the source says
TREXO ROBOTICS HOLDINGS Date Published : 07/05/2024 5700 Timberlea Blvd , Unit 9-10 , Mississauga, Ontario CANADA
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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 Home 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 - - 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 Home 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 - - NP Orthosis, Corrective Shoe 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
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html