Sensory Medical, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Sensory Medical, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OVP | Vibratory Counter-Stimulation | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN110011 | De Novo | Vibratory Counter-Stimulation | 2013-12-18 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-03-14.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sensory Aids Corp. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sensory Medical, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Sensory Medical, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Sensory Medical, Inc.?
The most frequent FDA product codes under this applicant name are OVP (Vibratory Counter-Stimulation, 1).
Next steps
- See all 0 Sensory Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OVP, Sensory Medical, 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.