510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Pivotal Health Solutions

Watertown, SD, US

PIVOTAL HEALTH SOLUTIONS appears in FDA device records in Watertown, SD. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
4
Registered establishments
2

510(k) clearance history

FDA records hold 2 510(k) clearances for Pivotal Health Solutions between 2010 and 2014. The busiest year on record is 2010, with 1. The most recent is 2014, with 1.

Clearances by year, as a table
510(k) clearance decisions for Pivotal Health Solutions, by decision year
YearClearances
20101
20141
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K131983ITRAC CERVICAL TRACTION SYSTEMITHSubstantially Equivalent
K101889DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICEITHSubstantially Equivalent

Registered establishments

FDA registered establishments for Pivotal Health Solutions, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30072786683007278668PIVOTAL HEALTH SOLUTIONS3003 9th Ave. SW, Watertown, SD 57201 US2026and 3 more, listed in full below
30345353003365828Pivotal Health Solutions800 48th St., Springfield, OR 97478 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0588-2026Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage tableThe heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.Class IIOpen, Classified
Z-0587-2026Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage tableThe heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.Class IIOpen, Classified
Z-2326-2024Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.Class IIOpen, Classified
Z-1250-2015Apollo (cold) Laser Desktop Control Units, Model AP2-DT. The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line.Class IITerminated

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Pivotal Health Solutions edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of , FDA export datePage updated Source: openFDA, public domain