Thor Photomedicine Inc.
Amersham Buckinghamshire, GB
THOR PHOTOMEDICINE INC. appears in FDA device records in Amersham Buckinghamshire, GB. FDA records list no 510(k) clearances, no PMA records and 3 registered establishments. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
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
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3034745472 | 3034745472 | THOR PHOTOMEDICINE INC. | 296 Beanville Road, Suite B, Randolph, VT 05060 US | 2026 | |
| 3003899624 | 3003899624 | THOR Photomedicine Ltd | Units 1 & 2 Anglo Office Park, Amersham Buckinghamshire HP7 9FB GB | 2026 | |
| 3006747388 | 3006747388 | Thor Photomedicine inc. | 8375 Jumpers Hole road, Millersville, MD 21108 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2419-2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-2418-2025 | Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: N/A | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-2417-2025 | Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-2416-2025 | Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary increase in local blood circulation, temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary relaxation of muscles. Component: No | The potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-0972-2024 | NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL | One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy | Class II | Open, Classified | |
| Z-0456-2024 | NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184. | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-0455-2024 | NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-0454-2024 | G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | Class II | Open, Classified | |
| Z-0453-2024 | NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, making the canopy difficult to lift. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain