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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 4350 Executive Drive, San Diego, CA, 92121
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3015316271
- DUNS Number
- —
Catalogue (1)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ActivForce 2 | Activ5-M | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 30, 2021 | Z-0385-2022 | — | open, classified | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration. |
| Nov 30, 2021 | Z-0386-2022 | — | open, classified | Due to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2) Firm failing to register and list its medical devices with U.S. Food and Drug Administration. |