Reference Source

TREXO ROBOTICS HOLDINGS · 89-08 · CANADA

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
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 Plus | Trexo Home | Trexo Home | Trexo Plus | Trexo Home | Trexo Plus | Trexo Plus | Trexo Home | Trexo Plus | Trexo Home 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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

— accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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