Silhouette Lift, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Silhouette Lift, Inc. makes
Silhouette Lift, Inc. manufactures orthopedic lifting devices, including the Silhouette InstaLift and Silhouette Featherlift, designed for patient transfer assistance in clinical settings. These products are intended to aid healthcare providers in safely moving patients with limited mobility or reduced strength. The devices are engineered to reduce manual lifting risks while supporting patient stability during transfers.
The company’s portfolio is classified under FDA Class II devices and requires 510(k) clearance for market authorisation in the United States. The devices are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance. The manufacturer operates from the United States.
Catalogue
Silhouette InstaLift Ref K163676
Regimes: 510(k) Registry: 510(k)Silhouette Featherlift Ref K171005
Regimes: 510(k) Registry: 510(k)Silhouette Instalift Ref K142061
Regimes: 510(k) Registry: 510(k)Silhouette Featherlift / Silhouette Lift Ref K191299
Regimes: 510(k) Registry: 510(k)Silhouette Instalift Ref K200140
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Silhouette Lift, Inc., initiated on 2015-07-02. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2015
- 2 Jul 2015 Z-2208-2015 Class II Terminated Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.
Full distribution text
- 2 Jul 2015 Z-2208-2015 Class II Terminated Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product.
Frequently asked questions
How many devices does Silhouette Lift, Inc. have in the registry?
The registry currently lists 5 devices for Silhouette Lift, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Silhouette Lift, Inc.'s devices?
Among its 5 most recently registered devices, Silhouette Lift, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Silhouette Lift, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Silhouette Lift, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Silhouette Lift, Inc.?
FDA recall records list 1 recall initiated by Silhouette Lift, Inc., the most recent initiated on 2 Jul 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Silhouette Lift, Inc. in the registry?
The most recently registered devices listed for Silhouette Lift, Inc. include Silhouette InstaLift, Silhouette Featherlift and Silhouette Featherlift / Silhouette Lift.