AlterG, Incorporated
Fremont, CA, US
AlterG, Incorporated appears in FDA device records in Fremont, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 2
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to AlterG, Incorporated carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Alter-G, Incorporatedrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1131-2014 | Accessory shorts for the AlterG Anti-Gravity treadmill. Use with the AlterG Anti-Gravity Treadmill for rehabilitation. | Unapproved material used by vendor in subset of shorts causing them to stretch more than usual and are uncomfortable for patient. | Class II | Terminated | |
| Z-3026-2011 | AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions. | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain