Nor-Am Patient Care Products, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Nor-Am Patient Care Products, Inc.” (first 1985, latest 1990), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 175 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | 5 | 5 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| ITH | Equipment, Traction, Powered | 1 | 1 |
Review panels
Most recent Nor-Am Patient Care Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900647 | SOUTHERN CROSS HI-V4 PULSED HIGH VOLTAGE GALVANIC | IPF | 1990-10-22 | 255 |
| K844390 | ESCOTEK-EST 204 MULTI STIM | IPF | 1985-05-07 | 175 |
| K844389 | ESCOTEK EST 210, HIGH VOLTAGE ELECTRO GALVANIC STI | IPF | 1985-05-07 | 175 |
| K844388 | ESCOTEK EST 220 INTERFERENCE THERAPY UNIT | IPF | 1985-05-07 | 175 |
| K844387 | ESCOTEK-EST 221 VACUUM UNIT | IPF | 1985-05-07 | 175 |
| K844386 | ESCOTEK-EST 301A ULTRA-SONIC UNIT | IMI | 1985-05-01 | 169 |
| K844385 | ESCOTEK EST TRAC 401 | ITH | 1985-05-01 | 169 |
Recalls
openFDA lists no recalls under a recalling firm named Nor-Am Patient Care Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nor-Am Patient Care Products, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Nor-Am Patient Care Products, Inc.” (first 1985, latest 1990), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nor-Am Patient Care Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nor-Am Patient Care Products, Inc. is 175 days.
Which FDA product codes appear under Nor-Am Patient Care Products, Inc.?
The most frequent FDA product codes under this applicant name are IPF (Stimulator, Muscle, Powered, 5); IMI (Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, 1); ITH (Equipment, Traction, Powered, 1).
Next steps
- See all 7 Nor-Am Patient Care Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IPF, Nor-Am Patient Care Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.