Normatec Industries, LP
Watertown, MA, US
NORMATEC INDUSTRIES, LP appears in FDA device records in Watertown, MA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Normatec Industries, LP between 2012 and 2025. The busiest year on record is 2016, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2016 | 2 |
| 2018 | 2 |
| 2022 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251905 | Normatec Elite Hip | IRP | Substantially Equivalent | |
| K240122 | Normatec Elite | IRP | Substantially Equivalent | |
| K221666 | Normatec Go | IRP | Substantially Equivalent | |
| K220217 | Normatec 3 | IRP | Substantially Equivalent | |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | IRP | Substantially Equivalent | |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | JOW | Substantially Equivalent | |
| K161346 | NormaTec PCD-T and PCD-B | JOW | Substantially Equivalent | |
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | IRP | Substantially Equivalent | |
| K112890 | NORMATEC MVP | IRP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003619590 | 3003619590 | NORMATEC INDUSTRIES, LP | 480 Pleasant Street, Suite A200, Watertown, MA 02472 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain