# Tommie Copper Inc (specification developer, Mount Kisco, NY): 1 new FDA device listing, incl. orthosis, limb, for back pain

**Score:** 55/100

| Field | Value |
|---|---|
| Establishment | Tommie Copper Inc |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Mount Kisco, NY, US |
| New listings | 1 |
| Devices | Orthosis, Limb, For Back Pain |
| Product codes | PMV |
| Device classes | Class I |
| Medical specialties | Physical Medicine |
| First new listing | 2026-06-02 |
| Latest new listing | 2026-06-02 |
| FDA registration number | 3010120748 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.